Asastd Ansi Asa S3 6-2010
Asastd Ansi Asa S3 6-2010
6-2010
(Revision of ANSI S3.6-2004)
Standards Secretariat
Acoustical Society of America
35 Pinelawn Road, Suite 114 E
Melville, NY 11747-3177
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The American National Standards Institute, Inc. (ANSI) is the national coordinator
of voluntary standards development and the clearinghouse in the U.S.A. for
information on national and international standards.
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ANSI/ASA S3.6-2010
(Revision of ANSI S3.6-2004)
Secretariat:
Abstract
The audiometers covered in this specification are devices designed for use in determining the hearing
threshold level of an individual in comparison with a chosen standard reference threshold level. This
standard provides specifications and tolerances for pure tone, speech, and masking signals and
describes the minimum test capabilities of different types of audiometers.
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AMERICAN NATIONAL STANDARDS ON ACOUSTICS
The Acoustical Society of America (ASA) provides the Secretariat for Accredited Standards
Committees S1 on Acoustics, S2 on Mechanical Vibration and Shock, S3 on Bioacoustics, S3/SC 1 on
Animal Bioacoustics, and S12 on Noise. These committees have wide representation from the
technical community (manufacturers, consumers, trade associations, organizations with a general
interest, and government representatives). The standards are published by the Acoustical Society of
America as American National Standards after approval by their respective Standards Committees
and the American National Standards Institute (ANSI).
These standards are developed and published as a public service to provide standards useful to the
public, industry, and consumers, and to Federal, State, and local governments.
Each of the Accredited Standards Committees (operating in accordance with procedures approved by
ANSI) is responsible for developing, voting upon, and maintaining or revising its own Standards. The
ASA Standards Secretariat administers Committee organization and activity and provides liaison
between the Accredited Standards Committees and ANSI. After the Standards have been produced
and adopted by the Accredited Standards Committees, and approved as American National Standards
by ANSI, the ASA Standards Secretariat arranges for their publication and distribution.
An American National Standard implies a consensus of those substantially concerned with its scope
and provisions. Consensus is established when, in the judgment of the ANSI Board of Standards
Review, substantial agreement has been reached by directly and materially affected interests.
Substantial agreement means much more than a simple majority, but not necessarily unanimity.
Consensus requires that all views and objections be considered and that a concerted effort be made
towards their resolution.
The use of an American National Standard is completely voluntary. Their existence does not in any
respect preclude anyone, whether he or she has approved the Standards or not, from manufacturing,
marketing, purchasing, or using products, processes, or procedures not conforming to the Standards.
NOTICE: This American National Standard may be revised or withdrawn at any time. The procedures
of the American National Standards Institute require that action be taken periodically to reaffirm,
revise, or withdraw this Standard.
© 2010 by Acoustical Society of America. This standard may not be reproduced in whole or in part in any form for
sale, promotion, or any commercial purpose, or any purpose not falling within the provisions of the U.S. Copyright
Act of 1976, without prior written permission of the publisher. For permission, address a request to the Standards
Secretariat of the Acoustical Society of America.
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Contents
Annex C (normative) Calibration of circumaural earphones for extended high frequency testing ...... 39
C.1 General.................................................................................................................................. 39
C.2 Calibration ............................................................................................................................. 39
C.3 Microphone............................................................................................................................ 39
C.4 Adapters for making extended high frequency measurements on an IEC 60318-1 ear
simulator ........................................................................................................................................ 39
C.5 Coupler configurations using a Type 1 adapter .................................................................... 39
C.6 Coupler configuration using a Type 2 adapter ...................................................................... 42
C.7 Environmental conditions ...................................................................................................... 42
C.8 References ............................................................................................................................ 42
Annex D (informative) Procedures for transfer of reference equivalent threshold values .................. 43
D.1 General.................................................................................................................................. 43
D.2 Probe-tube method ............................................................................................................... 43
D.3 Loudness-balance method .................................................................................................... 44
D.4 Threshold-determination method .......................................................................................... 44
D.5 Standard reference earphone with other-than-specified coupler .......................................... 44
D.6 Standard earphones with other-than-specified cushions ...................................................... 45
D.7 Earphone and coupler both different from standard types .................................................... 45
Annex E (informative) Audiogram format ............................................................................................ 46
E.1 General.................................................................................................................................. 46
E.2 Reference levels ................................................................................................................... 46
E.3 Vertical scale ......................................................................................................................... 46
E.4 Horizontal scale ..................................................................................................................... 46
E.5 Scale proportions .................................................................................................................. 46
Annex F (informative) Supra-aural cushions for earphones................................................................ 47
Tables
Table 2a — Required frequencies and hearing levels for various audiometers ................................... 14
Table 2b — Required frequencies and hearing levels for EHF audiometers ........................................ 14
Table 4 — Narrow-band masking noise: upper and lower cut-off frequencies and correction
factors for determining RETSPLs................................................................................................... 19
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Table 5 — Reference equivalent threshold sound pressure levels (RETSPLs) (dB re 20Pa) for
supra-aural earphones in common use.......................................................................................... 26
Table 6 — Reference equivalent threshold sound pressure levels (RETSPLs) (dB re 20µPa) for
circumaural earphones ................................................................................................................... 27
Table 7a — Reference equivalent threshold sound pressure levels (RETSPLs) (dB re 20Pa)
for ER-3A and EARTone 3A insert earphones............................................................................... 29
Table 7b — Reference equivalent threshold sound pressure levels (RETSPLs) (dB re 20Pa)
for ER-2 insert earphones for use at Extended High Frequency ................................................... 30
Table 8 — Reference equivalent threshold force levels (RETFLs) for bone vibrators .......................... 32
Table 9 — Reference equivalent threshold sound pressure levels (RETSPLs) (dB re 20 Pa) for
sound-field testing .......................................................................................................................... 33
Table A.1 — Difference between the free-field equivalent sensitivity level GF and the coupler or
acoustic coupler or ear simulator level GC for two types of earphones ......................................... 37
Figures
Figure 2 — Coupling of the insert earphone to the calibration coupler – Figure 2(a) shows an
occluded ear simulator (as described in ANSI/ASA S3.25 and IEC 60318-4 (IEC 60711)),
see subclause 9.3.1; Figure 2(b) an HA-2 acoustic coupler with rigid tube attachment (as
described in ANSI/ASA S3.7), see subclause 9.3.2; and Figure 2(c) an HA-1 acoustic
coupler (as described in ANSI/ASA S3.7), see subclause 9.3.3.................................................... 28
Figure C.1 — Type 1 adapter for use with IEC 60318-1 ear simulator ................................................. 40
Figure C.2 — Position of Type 1 adapter on the IEC 60318-1 ear simulator........................................ 40
Figure C.3 — Type 2 adapter for use with IEC 60318-1 ear simulator ................................................. 41
Figure C.4 — Position of Type 2 adapter on the IEC 60318-1 ear simulator........................................ 41
[This Foreword is for information only and is not a part of ANSI/ASA S3.6-2010 American National Standard
Specification for Audiometers.]
This standard comprises a part of a group of definitions, standards, and specifications for use in
bioacoustics. It was developed and approved by Accredited Standards Committee S3 Bioacoustics,
under its approved operating procedures. Those procedures have been accredited by the American
National Standards Institute (ANSI). The Scope of Accredited Standards Committee S3 is as follows:
Standards, specifications, methods of measurement and test, and terminology in the fields of
psychological and physiological acoustics, including aspects of general acoustics which pertain to
biological safety, tolerance and comfort.
This standard is a revision of ANSI S3.6-2004, which has been technically revised to incorporate
changes to keep this standard compatible with other equivalent international (IEC and ISO) standards.
This standard contains comparable information to current ISO Standards for pure tone thresholds,
bone conduction and sound field.
At the time this Standard was submitted to Accredited Standards Committee S3, Bioacoustics for
approval, the membership was as follows:
American Academy of Otolaryngology - Head and Neck Surgery ................................... .R.A. Dobie
....................................................................................................................................... L.A. Michael (Alt.)
Council for Accreditation in Occupational Hearing Conservation (CAOHC) ................... L.D. Hager
National Institute for Occupational Safety and Health (NIOSH) ................................. M. Stephenson
.......................................................................................................................................W.J. Murphy (Alt.)
U.S. Army Research Laboratory, Human Research and Engineering Directorate ......T.R. Letowski
............................................................................................................................................. P. Henry (Alt.)
Working Group S3/WG 35, Audiometric Equipment, which assisted Accredited Standards Committee
S3, Mechanical Vibration and Shock, in the development of this standard, had the following
membership:
Suggestions for improvements to this standard will be welcomed. They should be sent to Accredited
Standards Committee S3, Bioacoustics, in care of the Standards Secretariat of the Acoustical Society
of America, 35 Pinelawn Road, Suite 114E, Melville, New York 11747-3177. Telephone: 631-390-
0215; Fax: 631-390-0217; E-mail: asastds@aip.org.
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AMERICAN NATIONAL STANDARD ANSI/ASA S3.6-2010
1.1 Scope
Audiometers are electronic instruments intended for the testing of human hearing. This standard
includes specifications and tolerances for audiometers and standard reference threshold levels for
audiometric transducers such as supra-aural, circumaural, and insert earphones; bone vibrators; and
loudspeakers.
This standard classifies audiometers according to the type of signal generated (pure tones, speech, or
both), mode of operation, and complexity or range of auditory functions tested. Audiometers are also
classified by type. Audiometers used for diagnostic assessment are classified as Types 1, 2, or 3,
while audiometers having air-conduction facilities only are classified as Type 4.
1.2 Purpose
The purpose of this standard is to ensure that tests of hearing, and particularly tests of hearing
threshold, performed on the same individual with different audiometers complying with this standard
shall give equivalent results when used under comparable test conditions. Further, the test results
shall accurately and validly represent the level difference, if any, that may exist between the threshold
of the individual tested and the reference threshold of hearing. This standard covers the general
specifications for audiometers that require behavioral responses from a listener, as well as specific
requirements governing the functional units of audiometric equipment such as type or types of signal,
signal level control mechanisms, and types of transducers. In addition, instruments which are not
audiometers but are used primarily for audiometric testing purposes, which incorporate calibrated
sound sources (e.g., acoustic immittance systems, otoacoustic emission systems, or narrow-band
noise generators), shall, whenever possible, conform to clauses 4 through 10 of this standard.
1.3 Applications
This standard specifies requirements for audiometers used primarily to determine hearing threshold
levels with respect to standard reference threshold levels.
2 Normative references
The following referenced documents are indispensable for the application of this standard. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ANSI S1.4-1983 (R 2006) American National Standard Specification for Sound Level Meters
ANSI/ASA S3.1-1999 (R 2008) American National Standard Maximum Permissible Ambient Noise
Levels for Audiometric Test Rooms
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ANSI/ASA S3.6-2010
ANSI/ASA S3.2-2009 American National Standard Method for Measuring the Intelligibility of Speech
over Communication Systems
ANSI/ASA S3.7-1995 (R 2008) American National Standard Method for Coupler Calibration of
Earphones
ANSI S3.13-1987 (R 2007) American National Standard Mechanical Coupler for Measurement of
Bone Vibrators
ANSI/ASA S3.21-2004 (R 2009) American National Standard Methods for Manual Pure-Tone
Threshold Audiometry
ANSI/AAMI ES60601-1 Medical Electrical Equipment, Part 1: General Requirements for Basic Safety
and Essential Performance
IEC 60268-17 Ed. 1.0 b:1990 Sound system equipment, Part 17: Standard volume indicators
IEC 60318-1:2009 Electroacoustics – Simulators of human head and ear – Part 1: Ear simulator for
the measurement of supra-aural and circumaural earphones
IEC 60318-3:1998 Electroacoustics – Simulators of human head and ear – Part 3: Acoustic coupler for
the calibration of supra-aural earphones used in audiometry
IEC 60318-4: 2010 Electroacoustics – Simulators of human head and ear – Part 4: Occluded-ear
simulator for the measurement of earphone coupled to the ear by means of ear inserts (revision of IEC
60711:1981)
IEC 60318-5:2006 Electroacoustics – Simulators of human head and ear – Part 5: 2 cm3 coupler for
the measurement of hearing aids and earphones coupled to the ear by means of ear inserts
IEC 60318-6:2007 Electroacoustics – Simulators of human head and ear – Part 6: Mechanical coupler
for the measurement of bone vibrators
IEC 60601-1:2005 Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance
IEC 60601-1-2:2007 Medical electrical equipment – Part 1-2: General requirements for basic safety
and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and
tests
ISO 389-1:1998 Acoustics – Reference zero for the calibration of audiometric equipment – Part 1:
Reference equivalent threshold sound pressure levels for pure tones and supra-aural earphones
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ISO 389-2:1994 Acoustics – Reference zero for the calibration of audiometric equipment – Part 2:
Reference equivalent threshold sound pressure levels for pure tones and insert earphones
ISO 389-3:1994 Acoustics – Reference zero for the calibration of audiometric equipment – Part 3:
Reference equivalent threshold force levels for pure tones and bone vibrators
ISO 389-4:1994 Acoustics – Reference zero for the calibration of audiometric equipment – Part 4:
Reference levels for narrow-band masking noise
ISO 389-5:2006 Acoustics – Reference zero for the calibration of audiometric equipment – Part 5:
Reference equivalent threshold sound pressure levels for pure tones in the frequency range 8 kHz to
16 kHz
ISO 389-6:2007 Acoustics – Reference zero for the calibration of audiometric equipment – Part 6:
Reference threshold of hearing for test signals of short duration
ISO 389-7:2005 Acoustics – Reference zero for the calibration of audiometric equipment – Part 7:
Reference threshold of hearing under free-field and diffuse-field listening conditions
ISO 389-8:2004 Acoustics – Reference zero for the calibration of audiometric equipment – Part 8:
Reference equivalent threshold sound pressure levels for pure tones and circumaural earphones
ISO 389-9:2009 Acoustics – Reference zero for the calibration of audiometric equipment – Part 9:
Preferred test conditions for the determination of reference hearing threshold levels
ISO 8253-1:1989 Acoustics – Audiometric test methods – Part 1: Basic pure tone air and bone
conduction threshold audiometry
ISO 8253-2:1992 Acoustics – Audiometric test methods – Part 2: Sound field audiometry with pure
tone and narrow-band test signals
NOTE All definitions are technically equivalent to ANSI/ASA S3.20-1995; some have editorial differences and
have been expanded for the user of this standard.
3.1
Pure-tone audiometer
Instrument used to measure hearing sensitivity, specifically hearing level for pure tones, as a function
of frequency.
3.2
Extended high frequency audiometer
A pure-tone audiometer providing test frequencies in the 8000 to 16000 Hz range.
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3.3
Békésy or automatic recording audiometer
A pure-tone audiometer in which the frequency, repetition rate, and rate of change in amplitude of the
signal are automatically controlled, but in which the direction of change in signal level, whether
increasing or decreasing, is under control of the subject whose responses are recorded automatically.
3.4
Manual audiometer
A pure-tone audiometer in which the signal presentations, frequency, hearing level selection, and
recording the results are performed manually.
3.5
Computer-controlled audiometer
An audiometer in which the test procedure is controlled by means of a computer.
3.6
Speech audiometer
An audiometer which facilitates the use of either live or recorded speech or speech-like signals for
measurement of hearing.
3.7
Air conduction
Transmission of sound through the outer and middle ear to the inner ear.
3.8
Bone conduction
Transmission of sound to the inner ear primarily by means of mechanical vibration of the cranial
bones.
3.9
Equivalent threshold sound pressure level
At a specified frequency, for a specified type of earphone, and for a stated force of application of the
earphone to a human ear, the sound pressure level (SPL) generated by the earphone in a specified
acoustic coupler, or ear simulator when the earphone is driven by that voltage which, with the
earphone applied to the ear concerned, would correspond with the threshold of hearing. Abbreviation,
ETSPL.
3.10
Equivalent threshold force level
At a specified frequency, for a specified type of bone vibrator, and for a stated force of application of
the bone vibrator to a human head, the vibratory force level generated by the bone vibrator on a
specific mechanical coupler when the vibrator is driven by that voltage which, with the bone vibrator
applied to the mastoid prominence or to the forehead would correspond to the threshold of hearing
provided the non-test ear is adequately masked. Abbreviation, ETFL.
3.11
Reference equivalent threshold sound pressure level
The mean / modal equivalent threshold sound pressure level at a specified frequency, as measured in
a specified acoustic coupler or ear simulator, based upon hearing threshold data from a sufficiently
large number of otologically normal individuals of both genders ranging in age from 18 to 25 years.
Abbreviation, RETSPL; unit, decibel (dB).
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3.12
Reference equivalent threshold force level
The mean/modal equivalent threshold force level at a specified frequency as measured on a specified
mechanical coupler based upon hearing threshold data from a sufficiently large number of otologically
normal individuals of both genders, from 18 to 25 years of age. Abbreviation, RETFL; unit, decibel
(dB); symbol, LF.
3.13
Occlusion effect
Increase in loudness of bone-conducted signals, at frequencies below 2000 Hz when the external
ear(s) are covered. Typically observed in bone-conduction audiometry as an enhancement in
threshold when an ear is covered with an earphone (occluded) or external ear is occluded compared
with an ear being uncovered (unoccluded).
3.14
Hearing threshold
For a specified signal, the minimum sound pressure level or vibratory force level that is capable of
evoking an auditory sensation in a specified fraction of trials. The characteristics of the signal, the way
it is presented to the subject, and the method by which the sound pressure level or force level is
measured must be specified. Sound pressure levels and force levels are relative to the standard
reference of 20 µPa and 1µN, respectively. A pure-tone threshold measurement procedure is
described in ANSI/ASA S3.21 which recommends defining threshold as the lowest signal level at
which responses occur in at least 50% of a series of ascending trials.
3.15
Hearing level for pure tones
Hearing threshold of a given ear at a specified frequency and for a specified type of transducer when
measured with an audiometer calibrated to reference equivalent threshold levels for air or bone
conduction. The ETSPL or ETFL minus the appropriate RETSPL or RETFL. Abbreviation, HL.
3.16
Speech level
The sound pressure level or the vibratory force level of a speech signal as measured in an appropriate
coupler, ear simulator, or in a sound field with a specified frequency and time weighting.
NOTE 1 Speech level may be expressed as time-average C-weighted sound level, where the duration of the
integration is the duration of the speech signal. For speech test lists based on single items, the integration should
not include the silent interval between items. For test lists based on single test items with a carrier phrase, the
integration should include only the test items.
NOTE 2 For tests of single items, the time-average sound level may be estimated from the average of the
maximum C-weighted sound levels measured with fast time weighting.
3.17
Hearing level for speech
Hearing threshold of a given ear for a specified speech signal, for a specified type of transducer, and
for a specified manner of presentation calculated as the speech level minus the appropriate reference
equivalent speech recognition threshold level.
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3.18
Speech recognition threshold level
The lowest speech level for a given ear, for a specified speech signal, for a specified type of
transducer, and for a specified manner of presentation at which the speech signal is recognized 50%
of the time. Abbreviation, SRT.
NOTE Speech recognition threshold was previously called speech reception threshold.
3.19
Equivalent speech recognition threshold sound pressure level
For a specified speech signal, type of transducer, and manner of signal presentation: The sound
pressure level produced by a transducer in a specified acoustic coupler when the voltage applied to
the transducer is that which produces sound pressure at the speech recognition threshold when the
transducer is applied to an ear. Abbreviation, ESRTSPL.
3.20
Reference equivalent speech recognition threshold level
For a specified speech signal, type of transducer, and method of signal presentation, the mean value
of the speech recognition threshold levels of a sufficiently large number of otologically normal persons
of both genders aged 18 to 25 years inclusive, expressing the threshold of hearing in a specified
acoustic coupler. Abbreviation, RESRTL.
3.21
Free-field equivalent earphone sensitivity
The mean ratio of the progressive sound wave pressure level and the electrical signal applied to the
terminals of the earphone when the sound produced by the earphone is judged by at least 10
otologically normal subjects to be equivalent in loudness to the same signal generated as a plane
progressive sound wave of zero degree incidence (frontal presentation) in a sound field. Both sounds
to be compared shall be delivered to the same ear with the opposite ear occluded when an earphone
is evaluated.
3.22
Free-field equivalent bone vibrator sensitivity
The mean ratio of the progressive sound wave pressure level and the electrical signal applied to the
terminals of the vibrator when the sound produced by the vibrator is judged by at least 10 otologically
normal subjects to be equivalent in loudness to the same signal when it is generated as a plane
progressive sound wave of zero degree incidence (frontal presentation) in a sound field. Both sounds
to be compared shall be delivered to the same ear with the opposite ear masked.
3.23
Free-field equivalent earphone output level
The sound pressure level generated by an earphone expressed in terms of equivalent free-field sound
pressure level. See Annex A and Table A.1 for more information.
NOTE At a given frequency, this level is derived from the sound pressure level generated by the earphone in
an acoustic coupler or ear simulator by adding a correction figure representing the difference between the free-
field sensitivity level and the coupler sensitivity level for the type of earphone used at the given frequency.
3.24
Free-field equivalent bone vibrator output level
The vibratory force level generated by the bone vibrator expressed in terms of free-field equivalent
sound pressure level. This level is derived from the vibratory force level generated by the bone
vibrator on a mechanical coupler by adding the free-field bone vibrator correction for the given
frequency, type of bone vibrator, and type of mechanical coupler, or at a given frequency, the force
level produced by the bone vibrator on a mechanical coupler plus a correction consisting of the
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difference between the free-field sensitivity level and the coupler sensitivity level for the specified bone
vibrator. Unit, decibel (dB).
3.25
Ear simulator (artificial ear)
A device that presents to an earphone an acoustic impedance equivalent to that of the average human
ear and incorporates a calibrated microphone to measure the sound pressure level produced by the
earphone.
NOTE 2 An occluded ear simulator is specified in ANSI/ASA S3.25 and IEC 60318-4.
3.26
Acoustic coupler
Cavity of specified shape and volume used for the calibration of an earphone or microphone in
conjunction with a calibrated microphone adapted to measure the sound pressure level developed
within the cavity of the coupler.
NOTE 1 Acoustic couplers are specified in ANSI/ASA S3.7, IEC 60318-3, and IEC 60318-5.
3.27
Mechanical coupler (artificial mastoid)
Device presenting a specified mechanical impedance to a vibrator applied with a specified static force
and equipped with an electromechanical transducer to measure the alternating force level at the
surface of contact between vibrator and mechanical coupler.
3.28
Masking
The process by which the threshold of hearing for one sound is raised by the presence of another
(masking) sound.
The amount by which the threshold of hearing for one sound is raised by the presence of another
(masking) sound, expressed in decibels.
3.29
Effective masking level for pure tones
Sound pressure level of a band of noise whose geometric center frequency coincides with that of a
specific pure tone that masks the pure tone to 50% probability of detection. Abbreviation, EM.
NOTE 1 Effective masking level is analogous to hearing level, i.e., a measure of sound on a physical scale,
independent of the ear under test.
NOTE 2 On a normally hearing ear the amount of effective masking, abbreviated EM, is equal to the number of
decibels that a given band of noise shifts a pure-tone threshold. For example, 20 dB EM would produce a
threshold shift of 20 dB when the band of noise and the pure tone are presented simultaneously to the same ear.
NOTE 3 Typically, the output of a pure-tone audiometer for bands of noise is calibrated in effective masking
level.
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3.30
Effective masking level for speech
Sound pressure level of a specified masking noise that masks a speech signal to 50% probability of
recognition. The hearing level reference of the masking signal is equal to that of a speech recognition
threshold. Abbreviation EM.
NOTE On a normally hearing ear the amount of effective masking, abbreviated EM, is equal to the number of
decibels that a masking noise shifts a speech recognition threshold. For example, 20 dB EM would produce a
speech recognition threshold shift of 20 dB when the masking noise and speech signal are presented
simultaneously to the same ear.
3.31
Otologically normal subject
Person in a normal state of health who is free from all signs or symptoms of ear disease and from
excessive wax in the ear canal which would block incoming sound and who has no history of undue
exposure to noise.
Type designation shall be marked on the audiometer or indicated on its display. For example, if an
audiometer has pure tone Type 1 facilities and speech Type A facility, it will be designated with a
marking of ANSI/ASA S3.6 Type 1A. If extended high frequency facilities were added, the new
marking would be ANSI/ASA S3.6 Type 1HFA. Any combination of the following designations may
apply. See Table 1 for minimum required facilities.
5 General requirements
Audiometers shall conform to safety requirements specified in any of the standards listed below. The
manufacturer shall label the audiometer in accordance with the requirements set out in the specific
standard.
IEC 60601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety.
ANSI/AAMI ES60601-1 Medical Electrical Equipment, Part 1: General Requirements for Basic Safety
and Essential Performance
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As audiometers are capable of producing sound pressure levels that could be damaging to people
with normal hearing, a non-auditory indication to the operator is required for all hearing levels above
100 dB.
The maximum warm-up time for the audiometer shall be stated by the manufacturer and shall not
exceed 10 minutes when the unit has been stored at room temperature. All performance requirements
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shall be met after the stated warm-up time has elapsed and after any set-up adjustments prescribed
by the manufacturer have been carried out.
The specifications shall be met when any long-term deviation in supply voltage or mains frequency in
combination is the least favorable within the limits of ± 10% supply voltage and ± 5% mains frequency.
The specifications shall be met for the following short-term voltage reductions of the mains supply,
provided that the time interval between such a reduction and the next is at least 10 s:
When any other short-term line voltage variation occurs that can affect its operation, the audiometer
shall revert to a condition that will neither endanger the subject’s hearing nor yield invalid results.
Audiometers shall meet the requirements of IEC 60601-1-2 for electromagnetic compatibility (EMC).
During and as a result of any EMC immunity testing, the following shall be met: the audiometer shall
revert to a condition that will not endanger the hearing of the test subject. Under the EMC test
conditions the unwanted sound from any air conduction transducer shall not exceed a hearing level
corresponding to 80 dB.
During the EMC tests, the audiometer shall be equipped with all accessories and units specified by the
manufacturer. The following positions of the instrument facing the radiating antenna shall be tested: 0,
90, 180, and 270 degrees. The ambient noise in the EMC testing space shall be below 55 dB SPL
when measured with a third octave filter at 1 kHz. The hearing level control of the audiometer shall be
set to its minimum value, the frequency control to 1 kHz and the tone switch to “on” for the air
conduction transducer designated as being the right-hand earphone (if applicable).
The EMC tests shall be performed over the frequency range 80 MHz to 2.5 GHz in steps of 1%. Dwell
time for each frequency shall be appropriate to the instrument under test. Testing at a limited number
of frequencies does not negate the need to meet all requirements.
NOTE 1 To avoid possible effects of electromagnetic fields on the measuring microphone an acoustic tube
should be inserted between the audiometer earphone, together with a suitable adapter, or loudspeaker and the
measuring microphone in order to remove the microphone from the higher (EMC) test field.
NOTE 2 Because of the changes a mechanical coupler would cause in the electromagnetic field, this device
cannot be used to measure the output of bone vibrators in an electromagnetic field. A suitable method has not
been developed.
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The manufacturers of audiometers intended to be battery operated shall state the limits of battery
voltages within which the specifications will be met. A suitable indicator shall be provided to ensure
that the battery voltages are within the specified limits.
The specifications shall be met for all combinations of values of temperature within the range +15 °C
to +35 °C and relative humidity within the range of 30% to 90%.
Conformity with each of the specifications in subclauses 5.3.1 and 5.3.4 may be demonstrated with
one earphone by setting the audiometer to produce 100 dB SPL (or the maximum hearing level
setting, whichever is lower) at 1000 Hz and measuring test frequency, harmonic distortion, and sound
pressure level. Test frequency, harmonic distortion, and hearing level accuracy shall comply with
subclauses 6.1.4, 6.1.5, and 7.2.
NOTE If 1000 Hz is not provided by the audiometer, the nearest frequency should be used.
5.4.1 General
Objective acoustical measurements may not be feasible for testing certain characteristics of
audiometer performance. In such cases, subjective tests shall be performed using at least two
otologically normal subjects whose hearing threshold levels shall not exceed 10 dB HL from 250 to
8000 Hz. All subjective tests shall be conducted in an audiometric test room meeting the ambient
noise requirements for testing normal subjects with uncovered ears, as specified in ANSI/ASA S3.1.
Unwanted sound can occur in any transducer (e.g., earphone, insert earphone, bone vibrator,
loudspeaker, or monitor). Checking for crosstalk, breakthrough, or leakage between or from all
transducers is required and the requirements of subclauses 5.4.2.1 through 5.7 are to be met for all
transducers in any combination.
Unwanted sounds from an earphone can arise from electrical signals generated within an audiometer,
whether the tone switch is ON or OFF. Examples of these sounds are a hiss, hum, breakthrough, or
crosstalk. Requirements for the tone switch are described in subclause 7.5.2.
Unwanted sounds may be indirectly quantified by measuring the rms time-weighted (F) voltage
generated by the audiometer across a dummy load. A dummy load is a resistor, the value of which is
chosen to approximate the impedance of the transducer. The resulting voltage measurements are
then compared with the rms time-weighted voltage generated by the audiometer when the transducer
is producing a sound pressure level equal to the reference equivalent threshold sound pressure level.
The level difference between the two signals may then be calculated from the voltage ratio or may be
read directly from the measuring instrument if it offers that facility.
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With the tone switch in the OFF position, and with the hearing level control set at 60 dB HL, the
electrical signal in each one-third octave band within the range of 125 to 8000 Hz shall be at least -10
dB below the electrical signal corresponding to the RETSPL for the frequency at the center of the
band.
With the tone switch in the ON position, and with the hearing level control set to a value 70 dB HL, the
acoustical signal produced by the non-test transducer or the electrical signal generated across its
terminals or across a substitute dummy load shall be at least 70 dB below the corresponding
acoustical or electrical signal produced by, or driving, the test transducer.
When using speech signals, internal background noise from the transducers shall be no more than -10
dB HL, or at least 45 dB below the level of the test signal. The measurement for internal noise shall be
made acoustically with the transducer mounted on a coupler or ear simulator and the measuring
sound level meter set to the frequency-weighting A.
Subjective measurements of unwanted sound from either earphone shall be conducted with the tone
switch both in the ON and in the OFF positions. No test subject shall detect any sound other than the
test sound within the frequency range from 250 to 6000 Hz at any setting of the hearing level or
masking level controls at settings up to 70 dB HL. No test subject shall detect any sound other than
the test sound within the range of 125 to 16000 Hz at any setting of the hearing level or masking level
controls up to 50 dB HL. For higher settings, an external electrical attenuator shall be inserted in the
subject’s earphone connection. Tests for compliance at the higher settings shall be made with the
external attenuator set to a value equal to the number of decibels above the audiometer hearing level
settings minus 70 or 50 dB, respectively. The opposite earphone shall be disconnected and the
audiometer output terminals connected to an appropriate dummy load during the test.
In the Extended High Frequency range no test subject shall detect any unwanted sound from the
transducer coinciding with the presentation of the test tone, even at the maximum setting of the
hearing level control.
NOTE Many test subjects with almost no hearing ability at 14 kHz and 16 kHz have very good hearing at
lower frequencies; this fact is not taken into consideration in clause 5.4.1.
The manufacturer shall state the test frequencies at which the bone vibrator can radiate air-conducted
sound levels sufficient to invalidate the measurement of bone-conduction threshold in an unoccluded
ear. This can be tested as follows:
1) Establish threshold by bone conduction using mastoid placement at each test frequency ≥ 2000
Hz with each ear of the test subject occluded by an earplug that provides ≥ 20 dB of attenuation at test
frequencies of 2000 Hz and above.
2) Reestablish threshold by bone conduction at each test frequency ≥ 2000 Hz with the earplugs
removed and without moving the bone vibrator.
3) Sound radiated from the bone vibrator is negligible if the mean hearing threshold level as
determined under item (2), above, is no more than 3 dB lower than that determined under item (1),
above, at each test frequency for a group of 10 subjects who meet the requirements of subclause
5.4.1.
NOTE If this condition is not met directly at all frequencies, the unwanted sound radiation may be excluded by
inserting an ear plug into the external canal of the ear under test at the frequencies which are affected. Due to the
occlusion effect, use of the earplug is confined to frequencies of 2000 Hz and above.
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For audiometers designed to be used in the same room as the subject, any sound resulting from the
operation of the controls of an audiometer such as the tone switch or from acoustic radiation from the
audiometer, shall be inaudible at any setting up to and including 50 dB HL. The test for this
requirement shall be made using no fewer than two subjects who meet the requirements of subclause
5.4.1 while they are wearing the disconnected audiometer earphones at a distance of 1 meter from the
audiometer and while the outputs of the audiometer are terminated in dummy resistive loads equal to
the impedance of the earphones at 1000 Hz. The test shall be repeated with one ear of each subject
occluded by an earphone and with the bone-vibrator output terminated in an appropriate dummy load.
NOTE The limitation on noise from an audiometer or audiometer controls applies to any noise that could
provide the subject with a clue which could influence the test results. It is not intended to apply to a mechanism
such as an output selection switch or a detent on the frequency switch that could emit noise when the subject is
not actually being tested.
The subject response system informs the tester that the test signal has been perceived. Normally, the
response system is in the form of a hand-held switch which operates an indicator on the audiometer.
The subject switch provides direct control of the signal level in Békésy, automatic, and computer-
controlled audiometers. The switch shall be designed for easy and reliable operation with one hand. It
shall operate without generating any mechanical noise or electrical interference that could interfere
with the measurement of hearing threshold.
The monitoring system, if provided, shall be equipped with an electroacoustic system by which the
tester can listen to the signals presented through the audiometer by means of an earphone or a
loudspeaker. The level of the monitored signal shall be adjustable over a sufficient range, for example,
50 to 90 dB SPL, to meet the needs of the individual tester. The monitor level shall be independent of
the setting of the hearing level control and shall have no effect upon the test signal.
The talk-back system, if provided, shall be equipped with an electroacoustic system by which the
tester can listen to verbal responses of the subject to the test signals. A talk-back system consists of a
microphone, an amplifier with a level control, and an earphone or loudspeaker. The characteristics of
the talk-back system are not given, but it should permit a wide range of verbal responses to be heard
clearly.
6 Signal sources
The requirements for test frequencies and maximum hearing levels for various types of audiometers
are summarized in Table 2a and for EHF audiometers in Table 2b. Additional test frequencies may be
provided at one-third octave-band center frequencies up to 8000 Hz and at one-sixth octave-band
center frequencies up to 16000 Hz. RETSPL and RETFL values are given in Tables 5 through 8.
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The rate of frequency change for a Békésy or automatic recording audiometer shall be one octave per
minute. The minimum recording period at each frequency shall be 30 seconds for fixed-frequency
Békésy or automatic recording audiometers.
If frequency-modulated signals are provided, they shall have the following characteristics:
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The waveform of the modulating signal shall be either sinusoidal or triangular with symmetrical
increasing and decreasing portions on a linear or logarithmic frequency scale.
The stated repetition rate of the modulating signal shall be within the range from 4 to 20 Hz with a
tolerance of 10% of its stated value.
The stated total frequency deviation around the carrier frequency shall be in the range from 5% to
25% with a tolerance of 10% of its stated value.
The frequency accuracy (tolerance) for each test signal generated by a fixed-frequency audiometer
shall be ± 1% for Type 1 and 2 audiometers and for audiometers that provide extended high frequency
capabilities, and ± 2% for Type 3 and 4 audiometers.
The frequency accuracy of the test tone produced by a continuous sweep frequency audiometer shall
be within 5% of the frequency indicated on the audiogram.
The maximum level of the harmonics of the test tone relative to the level of the fundamental shall not
exceed the values given in Table 3. Harmonic distortion shall be measured at the hearing level listed
in the table or at the maximum hearing level setting on the audiometer, whichever is lower.
Harmonic distortion for air-conducted signals shall be measured acoustically with the transducer
mounted on an acoustic coupler or ear simulator of the same type as that used for the specification of
the appropriate RETSPL. Measurements of harmonics at frequencies above 5000 Hz could be
inaccurate because of limitations inherent in the acoustic coupler, ear simulator, or mechanical
coupler. Accordingly, electrical measurements shall be made across the terminals of the transducer at
frequencies above 5000 Hz.
Harmonic distortion for bone-conducted signals shall be measured with the transducer mounted on a
mechanical coupler. If the total distortion measuring method is used, the frequency response of the
mechanical coupler should be equalized. This precaution is unnecessary if a figure for total harmonic
distortion is derived from the force level measurement of discrete harmonic components.
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The clinical significance of speech audiometry is strictly related to the availability of standardized,
specially prepared and recorded speech material, along with a calibration signal.
Speech audiometry material has been standardized using audiometers having an uncorrected
frequency response as outlined in subclause 6.2.3. However, this frequency response does not
simulate a face-to-face talker-listener condition. To simulate such a condition, the earphone pressure
response on the coupler or ear simulator should be equalized to provide the same pressure response
at the eardrum as would be produced in a free field. The free-field equivalent output method is
fundamental in relating an earphone or bone vibrator output level to sound-field measurements and for
the comparison of different types of transducers. For audiometric purposes where measurements are
only made with one specific type of earphone, the free-field earphone relationship may not be
required. Therefore, in this standard, specifications of the performance characteristics of speech
audiometers and relevant calibration and test methods are given with respect to both a free-field
equivalent output level method and an uncorrected coupler output level method. Audiometers that
provide calibration in terms of a free-field equivalent output level shall be designated as Type E
speech audiometers.
For Type E speech audiometers, the output sound pressure level and overall frequency response
including the earphone shall be specified in terms of free-field equivalent sound pressure level.
NOTE Routine calibration can be performed using an acoustic coupler or ear simulator and applying
correction figures for the difference between the free-field equivalent sensitivity and the coupler sensitivity for the
type of earphone under test. Annex A gives the correction figures for certain types of commonly used earphones.
For audiometers which are not calibrated in terms of free-field equivalent output levels, the overall
frequency response of the speech audiometer including the earphone shall be specified in terms of
uncorrected sound pressure level measured in an acoustic coupler or ear simulator.
The output sound pressure level and overall frequency response of the audiometer including the
loudspeaker shall be specified as measured in a sound field at a minimum distance of 1 m on the
reference axis of the loudspeaker.
For Type E audiometers, the output vibratory force level and overall frequency response of the speech
audiometer including the bone vibrator shall be specified in terms of free-field equivalent sound
pressure level. If corresponding data for the type of bone vibrator used does not exist, the
characteristics shall be specified in terms of uncorrected vibratory force level measured on a
mechanical coupler.
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The output sound pressure level generated by the loudspeaker, insert earphones, or earphones with
any test signal in the frequency range from 250 to 4000 Hz shall not differ by more than 3 dB from the
average sound pressure level of all the test signals in this range. For any test signal between 125 and
250 Hz the tolerance is +0/-10 dB, and between 4000 and 6000 Hz it is ± 5 dB. For earphone
equivalent free-field output, correction figures representing the frequency-dependent difference
between the free-field sensitivity level and the coupler sensitivity level for the type of earphones used
shall be added to the measured coupler sound pressure levels before applying the tolerances. The
measurements for frequency response shall be made using white noise as a source connected to the
input for external signals. The resultant output is measured in appropriate couplers using one-third
octave filters.
For the bone vibrator output, the frequency response and tolerances in the range from 250 to 4000 Hz
shall be specified by the manufacturer.
If the audiometer has the means of replaying analog recorded speech material, the tolerance shall be
increased by 1 dB within the range from 250 to 4000 Hz, and 2 dB outside this range but within the
range from 125 to 8000 Hz (see Annex B).
For the test conditions given in subclause 6.2.6, the output voltage level generated at the terminals of
the microphone for any input test signal within the frequency range from 125 to 8000 Hz should not
differ by more than 3 dB from the average level of all test signals in this range. The test shall be
performed under free field or equivalent conditions using test signals of a constant sound pressure
level of 80 dB filtered from white noise by one-third octave filters.
The total harmonic distortion for the earphone output shall not exceed 2.5%. This shall be measured
with a pure tone signal applied to the electrical input of the audiometer at a level 9 dB above the
reference zero position of the signal level indicator. Test frequencies of 250, 500, and 1000 Hz shall
be used. The hearing level control shall be adjusted to produce a sound pressure level of 110 dB.
The total harmonic distortion for the loudspeaker output shall not exceed 3%. This shall be measured
with a pure tone input at the test frequencies 250, 500, and 1000 Hz and at a level 9 dB above the
reference zero position of the signal level indicator. At an output sound pressure level of 80 dB the
total harmonic distortion shall be less than 3%; at 100 dB SPL the total harmonic distortion shall be
less than 10%.
All speech test material shall be presented in relation to a standard reference level, as shown by a
monitoring meter provided in the audiometer meeting the requirements of IEC 60268-17. The meter
shall be connected at a point in the circuit before the hearing level control.
Provisions shall be made in the amplifier, preceding the monitoring meter, for easy adjustment of its
gain to cover a range of at least 20 dB in the level of input signals. If alternative automatic means are
provided for controlling the reference level, they shall produce the same result as would be obtained
with the above arrangement of gain control on the basis of a meter reading.
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For audiometers that have live-voice testing capabilities, the monitoring meter shall have the following
characteristics: (a) The scale shall be calibrated in decibels. The scale shall have a 0 dB reference
position within a sector between 2/3 and 3/4 of full scale. The scale shall display a maximum value of
+3 dB and a minimum value of -20 dB. (b) The response time to reach 99% of the reference 0 dB point
shall be 350 ± 10 ms and the indicator may overshoot the reference by 1% but no more than 1.5%. On
removal of the signal the recovery time shall not differ greatly from the response time. (c) The
response at any frequency between 250 and 8000 Hz shall not differ from that at 1000 Hz by more
than 0.5 dB.
For the purpose of this standard, the sound pressure level of a speech signal is defined as the level of
the rms sound pressure of a 1000 Hz signal adjusted so that the deflection of the volume level
indicator produced by the 1000 Hz signal is equal to the average peak deflection produced by the
speech signal. The level indicated by the monitoring meter for a preliminary carrier phrase may be
taken as the level indication of the speech material immediately following when the material is
delivered in a natural manner at the same communication level as the carrier phrase.
When speech materials such as words with a spondaic stress pattern or short sentences are used for
the test material, the standard reference sound pressure level shall be 12.5 dB above the 1000 Hz
standard RETSPL for a given transducer. When the level of the calibration signal is adjusted to bring
the indicator of the monitoring meter to its zero reference point and the hearing level control is set for
0 HL, the sound pressure level produced by the earphone shall be equal to the standard reference
equivalent sound pressure level for the speech recognition threshold.
This clause contains specifications for masking sounds for those pure-tone audiometers that provide
this facility. Measurements of the masking sound or sounds shall be made in an acoustic coupler, ear
simulator, or mechanical coupler.
NOTE Because of certain limitations inherent in transducers, acoustic couplers, and ear simulators, acoustic
spectrum measurements made with them at center frequencies above 3.15 kHz might not accurately describe the
spectrum of the masking noise. Accordingly, measurements at center frequencies above 3.15 kHz shall be made
electrically across the terminals of the transducer and shall be referred to the corresponding electrical voltage that
appears across the same terminals when the transducer is producing a sound pressure level equal to the
RETSPL at that test frequency.
Narrow-band noise, if provided, shall be centered geometrically around the audiometric test
frequencies. Band limits for narrow-band noise shall be as specified in Table 4. The sound pressure
level of the noise outside the tabulated limits shall fall at the rate of ≥ 12 dB per octave for at least
three octaves and thereafter not rise above –36 dB relative to the level at the center of the band.
NOTE 1 Each bandwidth at center frequencies ≥ 400 Hz, as specified in Table 4, corresponds to one-third
octave as a minimum, and one-half octave as a maximum. The specified bands are wider than the critical bands
for effective masking so as to minimize the perception of tonality that is associated with very narrow bands of
noise. The aim is to prevent the subject from confusing masker with signal.
NOTE 2 The derivation of the reference levels is based on the assumption that a noise band of critical
bandwidth just masks a tone of a frequency equal to the geometric center frequency of the band at a signal-to-
noise ratio of –4 dB, independent of frequency.
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NOTE 3 Specifications for critical bandwidths were taken from [1] and [2] in the Bibliography.
Table 4 — Narrow-band masking noise: upper and lower cut-off frequencies and correction
factors for determining RETSPLs
One-third One-half
Center Lower cut-off Upper cut-off octave octave
frequency frequency a frequency a correction to correction to
(Hz) (Hz) (Hz) RETSPL b RETSPL b
Min. Max. Min. Max. (dB) (dB)
125 105 111 140 149 4 4
160 136 143 180 190 4 4
200 168 178 224 238 4 4
250 210 223 281 297 4 4
315 265 281 354 375 4 4
400 336 356 449 476 4 5
500 420 445 561 595 4 6
630 530 561 707 749 5 6
750 631 668 842 892 5 7
800 673 713 898 951 5 7
1000 841 891 1120 1190 6 7
1250 1050 1110 1400 1490 6 8
1500 1260 1340 1680 1780 6 8
1600 1350 1430 1800 1900 6 8
2000 1680 1780 2240 2380 6 8
2500 2100 2230 2810 2970 6 8
3000 2520 2670 3370 3570 6 7
3150 2650 2810 3540 3750 6 7
4000 3360 3560 4490 4760 5 7
5000 4200 4450 5610 5950 5 7
6000 5050 5350 6730 7140 5 7
6300 5300 5610 7070 7490 5 6
8000 6730 7130 8980 9510 5 6
9000 7570 8020 10100 10700 5
10000 8410 8910 11220 11890 5
11200 9420 9980 12570 13320 5
12500 10510 11140 14030 14870 5
14000 11770 12470 15710 16650 5
16000 13450 14250 17960 19030 5
a
Cut-off frequencies are specified at the -3 dB points of the spectral density.
b
Values from ISO 389-4. Reference effective masking levels are calculated by adding the appropriate value to the
RETSPL at each frequency.
The sound pressure spectrum level of a white noise or broadband noise, if provided, shall be within
5 dB of the level at 1000 Hz at frequencies from 250 to 5000 Hz when measured in the acoustic
coupler or ear simulator.
The spectrum of weighted random noise for the masking of speech, if this facility is provided, shall be
so shaped that the sound pressure spectrum level shall be constant from 100 to 1000 Hz, decreasing
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thereafter at a rate of 12 dB per octave from 1000 to 6000 Hz. The tolerance for this specification is
5 dB. For Type E audiometers the correction figures for the difference between the free-field sensitivity
and the coupler sensitivity of a given transducer shall be applied.
7.1 Marking
The signal level control shall be identified by the designation (HL) “hearing level.” This designation
shall appear either on the front panel or on the hearing level control. The zero marking on the hearing
level control shall correspond to an output from the transducers which relates to the reference
equivalent threshold values given in the relevant parts of ISO 389. The maximum hearing level setting
for each frequency and transducer shall be automatically limited or otherwise indicated.
7.2 Accuracy of sound pressure and vibratory force level for pure-tone and speech
Measurements for conformity with all clauses shall be made with a measurement instrument meeting
the accuracy requirements for Type 1 sound level meters per ANSI S1.4. Recommendations for
periodic calibration intervals can be found in Annex G.
Inclusive of all other allowed deviations, the sound pressure level produced by the earphone(s) or
loudspeaker, or the force level produced by the bone vibrator, shall differ by no more than ± 3 dB from
the indicated value at any setting of the hearing level dial at test frequencies from 125 through 5000
Hz, and by no more than ± 5 dB at 6000 Hz and higher.
If more than one channel for signal or noise, or both, can be connected simultaneously to a single
transducer, the output level of either signal or noise from the transducer with both channels
connected, but with one channel turned off, shall differ by less than 1 dB from the level obtained when
one channel is connected. This requirement shall be met at frequencies from 125 through 4000 Hz
and with a tolerance of 2 dB at frequencies of 6000 Hz and higher. This requirement shall apply to
hearing levels up to 20 dB below the maximum output level. Sweep frequency Békésy or automatic
recording audiometers shall meet the above requirements at one-third octave-band center
frequencies.
Measurements for conformity with the provisions of clause 7 (Signal level controls) should be made
acoustically with the earphone mounted on an acoustic coupler or ear simulator, or the bone vibrator
mounted on a mechanical coupler. Where environmental noise precludes measurements at a setting
of ≤ 50 dB HL, electrical measurements can be made using a dummy load that approximates the
impedance of the transducer at each audiometer test frequency.
7.3.1 Increments
The hearing level indicators shall have only one scale. Indicator readings of hearing level for all types
of audiometers shall be calibrated in increments of 5 dB or less with 0 dB at each frequency
corresponding to the reference equivalent threshold level.
The signal level shall change at a rate of 2.5 dB per second (dB/s) for Type 1, 2, or 3 audiometers.
Additional rates, if provided, shall be 1.25 dB/s or 5 dB/s or a combination thereof. The rate of signal
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level change for Type 4 audiometers which provide extended high frequency threshold measuring
capabilities shall be 2.5 dB/s or 5 dB/s.
The tolerance for all of the above measures shall be ± 20%. The manufacturer shall state the
resolution of the hearing level control.
The measured difference in output between two successive indications of hearing level which are not
more than 5 dB apart shall not differ from the indicated difference on the indicator by more than three-
tenths of the indicated interval measured in decibels or by more than 1.5 dB from the indicated HL
value in the range of -10 dB HL to 0 dB HL, 1.4 dB in the range of 5 dB HL to 40 dB HL, and 1.2 dB in
the range of 45 dB HL and up, whichever is the smaller.
For automatic-recording audiometers, the measured difference in output between two successive
indications of hearing level which are not more than 5 dB apart shall not differ from the indicated
difference on the indicator by more than three-tenths of the indicated interval measured in decibels or
by more than 1.5 dB from the indicated HL value in the range of -10 dB HL to 0 dB HL, 1.4 dB in the
range of 5 dB HL to 40 dB HL, and 1.2 dB in the range of 45 dB HL and up, whichever is the smaller.
The masking level control shall have only one reference zero point that is common for all frequencies.
The masking level shall be adjustable in steps of 5 dB or less.
For narrow-band and speech masking noise the masking level control shall be calibrated in decibels of
effective masking.
The narrow-band masking sound produced by the earphone in an acoustic coupler or ear simulator
when the effective masking level control is at 0 dB shall, within each one-third octave band that is
geometrically centered around the test frequencies listed in Table 4, have a sound pressure level
equal to the corresponding RETSPL, plus the correction value also shown in Table 4 (see ISO 389-4).
The speech masking sound produced by the earphone in an acoustic coupler or ear simulator when
the effective masking level control is at 0 dB shall produce a sound pressure level equal to the
reference equivalent threshold sound pressure level (RETSPL) for speech.
For other masking signals (such as white noise) the manufacturer shall specify the frequency
spectrum and use. The masking level control may be calibrated in sound pressure level or in effective
masking. The masking level control shall be clearly marked as to whether the scale refers to sound
pressure level or effective masking.
The masking sound level shall differ from the indicated value by no more than +5/-3 dB. Conformity
with the specification shall be demonstrated by measuring the output at a hearing level setting of 70
dB at all available frequencies, with time weighting S, frequency response Z, and the same acoustic
coupler or ear simulator as used for the measurement of pure tones.
Masking level control linearity shall comply with the requirements shown in clause 7.3.3. The earphone
shall be mounted on an acoustic coupler or ear simulator for these measurements.
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The masking sound shall be adequate to mask tones at 60 dB HL at 250 Hz, 75 dB HL at 500 Hz, and
80 dB HL from 1000 to 8000 Hz. The maximum effective masking level regardless of test frequency
shall not exceed 115 dB SPL. The level of the masking sound shall be adjustable from 0 dB EM to the
effective masking level corresponding to the maximum hearing levels stated above.
Manual audiometers shall be provided with a tone switch for the presentation or the interruption of the
test tone. The switch and its associated circuitry shall be such that the subject will respond to the test
tone rather than to mechanical noise (see subclause 5.4.4) or to switching transients.
NOTE An audiometer may be equipped with a gating function for controlling the duration, repetition rate, or
both of a tone pulse.
The output from an earphone shall be 10 dB below the reference equivalent threshold level with the
tone switch in the OFF position and the hearing level control set at 60 dB HL or below. The output at
higher settings of the hearing level control, again with the tone switch OFF, shall not rise by more than
10 dB for each 10 dB increase in hearing level setting above 60 dB HL.
The rise and fall characteristics are illustrated in Figure 1. Letters are used to help specify these
characteristics:
Rise Time: When a tone is initiated: A-C shall not exceed 200 ms; B-C shall be no less than 20
ms, and the sound pressure level of the signal shall rise progressively without discontinuities.
Fall Time: When a tone is terminated: D-H shall not exceed 200 ms; E-G shall be no less than 20
ms, and the sound pressure level of the signal shall fall progressively without discontinuities.
Overshoot: The sound pressure level produced by the transducer shall not exceed +1 dB relative
to its steady state level during either its rise or fall.
If the audiometer provides facilities for pulsed tones, it shall be provided with a switch to change the
mode of presentation of the test tone from continuously on to automatically pulsed. In pulsed mode,
the signal envelope shall meet the following requirements:
Rise Time (B-C): shall be no less than 20 ms and shall not exceed 50 ms, and the sound
pressure level of the signal shall rise progressively without discontinuities.
Fall Time (E-G): shall be no less than 20 ms and shall not exceed 50 ms, and the sound pressure
level of the signal shall fall progressively without discontinuities.
Duration of Plateau (C-E): The plateau of the signal shall be no less than 150 ms in duration.
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On/Off Times: F-J and J-K shall each have values of 225 ± 35 ms.
On/Off Ratio: Between G and I the output shall remain at least 20 dB below the maximum
reached in the ON phase C-E.
In addition to all other requirements, Békésy and automatic audiometers shall be validated to meet the
requirements of subclauses 7.5.1, 7.5.2, and 7.5.3, and if an automatically pulsed tone is provided,
subclause 7.5.4.
The manufacturer shall specify the duration of the time window during which the patient may respond
and the algorithm governing the test procedure.
Computer-controlled audiometers shall meet the requirements for manual and automatic recording
audiometers and shall have means of indicating the hearing level of the signal being presented.
8 Reference-signal facilities
Some audiometric procedures require the use of a second signal, the level of which can be
independently controlled by the use of a second channel. Such a two-channel audiometer will permit
the alternate or simultaneous presentation of two signals with control of stimulus duration and inter-
stimulus interval. The requirements for the second channel are the same as those for a single channel
audiometer except as listed in subclauses 8.1 through 8.2.4.
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8.1 Frequencies
8.2.1 Range
The reference-signal level control shall offer a range from 0 dB HL to no less than 80 dB HL at 250 Hz
and to no less than 100 dB HL at 500 to 6000 Hz.
8.2.2 Increments
Either the test tone level or the reference tone level shall be adjustable in increments of 2.5 dB or less.
NOTE The control normally intended for the masking level may be used as the reference signal level control
providing that the requirements of subclauses 8.2.3 and 8.2.4 are met.
8.2.3 Accuracy
The performance of the reference signal level control shall conform to the requirements of subclause
7.2. Also, for the same hearing level settings and for the same frequency, the sound pressure level of
the reference signal shall be within 3 dB of the test tone level for frequencies from 500 to 4000 Hz
inclusive. For other test frequencies, a deviation of 5 dB is acceptable.
8.2.4 Operation
Operation of the reference signal level control shall not influence the output of the test signal by more
than 1 dB.
Other air-conduction sources may be used, provided standard RETSPLs are determined using the
procedures as covered in Annex D and that the calibration procedure is described by the
manufacturer.
RETSPL can be considered independent of a particular supra-aural earphone if the RETSPL values
refer to an ear simulator having acoustic properties simulating those of the average human ear. A
device meeting this requirement is described in ANSI/ASA S3.7 and IEC 60318-1 and is the ideal
method of calibration.
Other RETSPLs depend on the model of earphone and the type of acoustic coupler (NBS 9A / IEC
60318-3) used for calibration. The data shown in Table 5 are applicable to supra-aural earphone
cushions meeting the following requirements:
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2) The construction and material shall be suitable to provide a good acoustical seal between the
earphone and its cushion and also provide a good seal with the outer ear.
3) The circle of contact of the earphone in its cushion with a plane surface shall be of a diameter
comparable to the sagittal dimensions of the human pinna.
4) No part of the earphone in its cushion shall protrude beyond the plane of contact as defined in
item (3) above, and the recess shall be approximately in the form of a truncated cone.
5) The contour of the earphone in its cushion shall be such that contact with an acoustic coupler or
ear simulator of the type specified in IEC 60318-1 shall be at a diameter of 25 mm.
NOTE This requirement means that the angle of the vertex of any cone tangential to the earphone contour
on a diameter exceeding 25 mm will be greater than 116 degrees.
6) The cushion shall not deform when it is applied to an acoustic coupler or ear simulator.
Compliance with this requirement is met if the sound pressure level of a 1000 Hz signal transduced by
the earphone does not result in a change of more than 0.2 dB when the force of application is
changed from 5 N to 10 N.
7) The contour of the earphone in its cushion shall be such that when it is placed on the outer ear,
contact is made solely with the pinna and not with the surface of the skin covering the cranial bone
located posterior to the pinna.
8) The earphones shall be mounted on a headband that applies them to the outer ear with a force
between 4 and 5 N. This requirement is met if the application force exerted by the headband is 4.5
± 0.5 N when the earphones are separated horizontally by 145 mm and the top center of the
headband is 129 mm above an imaginary line between the earphone centers.
See Annex F for illustrations of two cushions which meet these requirements.
Earphones having the characteristics described in subclause 9.1.1 shall be calibrated using an IEC
60318-1 ear simulator or an IEC 60318-3/NBS 9A coupler. During calibration the earphone shall be
applied to the acoustic coupler or ear simulator with a static force of 4.5 N. The manufacturer shall
provide valid RETSPL values for earphones other than those listed in Table 5.
RETSPLs for various earphones in common use are found in Table 5. When these values are used,
the RETSPL for a TDH-39 earphone calibrated in an acoustic coupler NBS 9A or IEC 60318-3 may be
in error by as much as 5 dB at 6.0 kHz due to an interaction of the earphone and the coupler. Use of
an ear simulator, such as the IEC 60318-1, will prevent this from occurring (Lutman and Qasem,
1998).
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Table 5 — Reference equivalent threshold sound pressure levels (RETSPLs) (dB re 20Pa) for
supra-aural earphones in common use
Supra-aural earphone
Frequency Earphone typea TDH 39 TDH 49/50
Hz IEC 60318-1 NBS 9A NBS 9A
125 45.0 45.0 47.5
160 38.5
200 32.5
250 27.0 25.5 26.5
315 22.0
400 17.0
500 13.5 11.5 13.5
630 10.5
750 9.0 8.0 8.5
800 8.5
1000 7.5 7.0 7.5
1250 7.5
1500 7.5 6.5 7.5
1600 8.0
2000 9.0 9.0 11.0
2500 10.5
3000 11.5 10.0 9.5
3150 11.5
4000 12.0 9.5 10.5
5000 11.0
6000 16.0 15.5 13.5
6300 21.0
8000 15.5 13.0 13.0
Speech 20.0 19.5 20.0
a
any supra aural earphone having the characteristics described in clause 9.1.1 or ISO 389-1.
RETSPLs are given in Table 6 for two types of earphones using circumaural cushions when calibrated
using an IEC 60318-1 ear simulator equipped with a flat plate adapter, as described in subclauses C.4
and C.5. If other types of circumaural earphones or couplers are provided with the audiometer, the
RETSPLs shall be stated by the manufacturer together with the origin and rationale for the data.
The earphones shall be mounted on a headband which provides a force between 9 and 10 N. This
requirement is met if the application force exerted by the headband is between 9 and 10 N when the
earphones are separated horizontally by 145 mm and the top center of the headband is 129 mm
above an imaginary line between the earphone centers.
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Table 6 — Reference equivalent threshold sound pressure levels (RETSPLs) (dB re 20µPa) for
circumaural earphones
(See Annex C for calibration methods.)
Sennheiser
Koss HV/1A
HDA200
125 30.5
250 18
500 11
750 6
1000 5.5 16
1500 5.5
2000 4.5
3000 2.5
4000 9.5 8
5000 14
6000 17
8000 17.5 15.5
9000 19 19.5
10000 22 24
11200 23 23
12500 27.5 25
14000 35 34.5
16000 56 52
Speech 19
Reference ISO 389-5 (8kHz - 16kHz) and
RETSPLs ISO 389-8 (125Hz - 8kHz)
a
Though this earphone is no longer in production, some users still
need the RETSPL values. They are therefore given, and the
description of positioning of an adapter for calibration can be
found in Annex C.
This section describes calibration procedures and RETSPLs for insert earphones known as Etymotic
ER-3A, EARtone 3A, and ER-2 insert earphones. These insert earphones consist of a shoulder-
mounted transducer, sound tube, nipple adapter, and a foam eartip. The output of the transducer is
connected to a plastic sound tube having a nominal length of 240 mm and a nominal internal diameter
(ID) of 1.37 mm. The sound tube is connected to one end of a nipple adapter having a nominal length
of 11 mm and nominal ID of 1.37 mm. The other end of the nipple adapter is connected to a plastic
tube called an eartip tube which runs through and attaches to a foam eartip. The eartip tube has an ID
of 1.93 mm and a total length of 26 mm but a nominal effective length of 23 mm, as measured
between the end of the foam eartip and the end of the sound tube nipple. The foam eartip has a
nominal diameter of 13 mm and a nominal length of 12 mm (see ISO 389-2 and reference number
[12]).
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Figure 2 shows how an insert earphone is connected to different coupler types for the purpose of
calibration.
Figure 2 — Coupling of the insert earphone to the calibration coupler – Figure 2(a) shows an
occluded ear simulator (as described in ANSI/ASA S3.25 and IEC 60318-4 (IEC 60711)), see
subclause 9.3.1; Figure 2(b) an HA-2 acoustic coupler with rigid tube attachment (as described
in ANSI/ASA S3.7), see subclause 9.3.2; and Figure 2(c) an HA-1 acoustic coupler (as described
in ANSI/ASA S3.7), see subclause 9.3.3
Table 7a shows the RETSPLs for an insert earphone for various coupler types. The RETSPLs shown
in Table 7a are valid when the end of the foam eartip or other type of eartip is inserted to a depth of 12
to 15 mm from the entrance of the ear canal. The RETSPLs shown in Table 7a are based on a foam
eartip having the length of 12 mm.
Figure 2(a) shows an insert earphone coupled to an occluded ear simulator as described in ANSI/ASA
S3.25 and IEC 60318-4 (IEC 60711) for the purpose of output calibration. Specifically, the eartip tube
is removed from the nipple adapter and the nipple adapter is connected to the tube adapter of the
occluded ear simulator via a 5 mm long piece of No. 13 tubing so that the nipple adapter outlet will be
held tightly flush against the inlet of the tube adapter.
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Table 7a — Reference equivalent threshold sound pressure levels (RETSPLs) (dB re 20Pa) for
ER-3A and EARTone 3A insert earphones
Coupler type
Frequency
Occluded ear HA-2 with rigid
(Hz) HA-1b
simulatora tubea
125 28.0 26.0 26.5
160 24.5 22.0 22.0
200 21.5 18.0 19.5
250 17.5 14.0 14.5
315 15.5 12.0 15.0
400 13.0 9.0 10.5
500 9.5 5.5 6.0
630 7.5 4.0 4.5
750 6.0 2.0 2.0
800 5.5 1.5 1.5
1000 5.5 0.0 0.0
1250 8.5 2.0 1.0
1500 9.5 2.0 0.0
1600 9.5 2.0 1.5
2000 11.5 3.0 2.5
2500 13.5 5.0 4.5
3000 13.0 3.5 2.5
3150 13.0 4.0 2.5
4000 15.0 5.5 0.0
5000 18.5 5.0 1.5
6000 16.0 2.0 -2.5
6300 16.0 2.0 -2.0
8000 15.5 0.0 -3.5
Speech 18.0 12.5 12.5
a
RETSPLs using an occluded ear simulator (ANSI/ASA S3.7, IEC 60318-4, IEC 60711) and HA-2
coupler with rigid tube attachment (ANSI/ASA S3.7) are from ISO 389-2.
b
The above values are valid when the end of the foam eartip or other eartip is inserted to a depth
of 12 to 15 mm from the entrance to the ear canal. These values are based on a foam eartip
having the length of 12 mm.
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Table 7b — Reference equivalent threshold sound pressure levels (RETSPLs) (dB re 20Pa) for
ER-2 insert earphones for use at Extended High Frequency
Having coupled the insert earphone to an occluded ear simulator as described above and shown in
Figure 2(a), the sound pressure levels delivered by an insert earphone developed in the coupler that
correspond to the RETSPLs from 125 to 8000 Hz are shown in Table 7a in the column labeled
“occluded ear simulator” and RETSPLs for 8000 to 16000 for a specific insert earphone in Table 7b.
9.3.2 Reference levels in an HA-2 acoustic coupler with rigid tube attachment
Figure 2(b) shows an insert earphone coupled to an HA-2 acoustic coupler with rigid tube attachment
as described in ANSI/ASA S3.7 for the purpose of output calibration. Specifically, the earmold
substitute is placed in the HA-2 acoustic coupler. The tube adapter is placed on top of the earmold
substitute and is covered by a rubber gasket and screw-on cap; the rubber gasket and screw-on cap
are not shown in Figure 2(b). The insert earphone eartip is removed from the nipple adapter and the
nipple adapter is connected to the tube adapter of the HA-2 acoustic coupler via a 5 mm long piece of
No. 13 tubing so that the nipple adapter outlet will be held tightly flush against the inlet of the tube
adapter.
Having coupled the insert earphone to an HA-2 acoustic coupler with rigid tube attachment as
described above and shown in Figure 2(b), the sound pressure levels delivered from the insert
earphone developed in the coupler that correspond to the RETSPLs from 125 to 8000 Hz are shown
in Table 7a in the column labeled “HA-2 with rigid tube”.
NOTE The RETSPL value in an occluded ear simulator may be transferred to an HA-2 coupler with rigid tube
attachment for an insert earphone. The transfer process involves determination of the earphone terminal voltages
that produce RETSPLs in the occluded ear simulator. The insert earphone is then coupled to an HA-2 coupler
with rigid tube attachment and the procedure is repeated. The sound pressure levels developed in the HA-2
coupler with rigid tube attachment are then used to transfer the RETSPL for the insert earphone when calibrated
with this coupler.
Figure 2(c) shows an insert earphone coupled to an HA-1 acoustic coupler as described in ANSI/ASA
S3.7 for the purpose of calibration. Specifically, the bottom of the foam eartip is sealed to the top of
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the HA-1 acoustic coupler cavity so that the eartip tube opening is centered over the cavity sound inlet
hole. It is important that there is a complete seal between the bottom of the foam eartip and the top of
the cavity of the acoustic coupler.
Having coupled the insert earphone to an HA-1 coupler as described above and shown in Figure 2(c),
the sound pressure levels delivered by an insert earphone developed in the coupler that corresponds
to the RETSPLs from 125 to 8000 Hz are shown in Table 7a in the column labeled “HA-1.”
NOTE The RETSPL value in an occluded ear simulator may be transferred to an HA-1 coupler for an insert
earphone. The transfer process involves determination of the earphone terminal voltages that produce RETSPLs
in the occluded ear simulator. The insert earphone is then coupled to an HA-1 coupler and the procedure is
repeated. The sound pressure levels developed in the HA-1 coupler are then used to transfer the RETSPL for the
insert earphone when calibrated with this coupler.
For audiometers providing facilities for bone-conduction measurements, these clauses shall apply.
Any airborne sound radiating from the bone vibrator when it is in contact with the head of the test
subject shall meet the requirements of subclause 5.4.3.
A headband shall be provided that holds the bone vibrator in position with a static force of 5.4 ± 0.5 N
when the headband is spread to a width of 145 mm for mastoid, or to 190 mm for forehead
application. The top center of the headband shall be 129 mm above an imaginary line between the
center of the vibrator and the center of the support on the opposite end of the headband.
NOTE The skin covering the mastoid process of the temporal bone is recognized as a suitable site for
placement of the bone vibrator. This does not preclude the use of another site, such as the forehead, if the
location is clearly identified and appropriate calibration data are provided.
Reference equivalent threshold force levels are given in Table 8. These values are applicable to all
bone vibrators having a plane circular tip, with a nominal area of 175 ± 25 mm2 and provided with a
headband as specified in subclause 9.4.2. These vibrators are calibrated using a mechanical coupler
as specified in ANSI S3.13 or IEC 60318-6. During calibration the vibrator shall be applied to the
coupler with a static force of 5.4 ± 0.5 N. The zero setting of the hearing level control of the audiometer
shall also apply for bone conduction for a stated placement of the bone vibrator.
It is necessary to apply masking noise to the ear not under test, since excitation of the skull by the
vibrator may be heard by the ear not under test. The RETFLs listed in Table 8 are based on 40 dB EM
being applied to the non-test ear.
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Table 8 — Reference equivalent threshold force levels (RETFLs) for bone vibrators
Frequency Mastoid Forehead Forehead
(Hz) (dB re 1μN) (dB re 1μN) minus mastoid
250 67.0 79.0 12.0
315 64.0 76.5 12.5
400 61.0 74.5 13.5
500 58.0 72.0 14.0
630 52.5 66.0 13.5
750 48.5 61.5 13.0
800 47.0 59.0 12.0
1000 42.5 51.0 8.5
1250 39.0 49.0 10.0
1500 36.5 47.5 11.0
1600 35.5 46.5 11.0
2000 31.0 42.5 11.5
2500 29.5 41.5 12.0
3000 30.0 42.0 12.0
3150 31.0 42.5 11.5
4000 35.5 43.5 8.0
5000 40.0 51.0 11.0
6000 40.0 51.0 11.0
6300 40.0 50.0 10.0
8000 40.0 50.0 10.0
Speech 55.0 63.5 8.5
The environment in which sound-field audiometry is undertaken may vary considerably. In practice it is
not always possible to achieve a free-field test environment. Thus, test conditions for a quasi-free
sound field are given.
(2) The loudspeaker shall be arranged at the head-height of a seated listener, the reference axis
being directed through the reference point. The distance between the reference point and the
loudspeaker shall be at least 1 m.
(3) With the test subject and the subject's seat absent, the sound pressure level produced by the
loudspeaker at positions 0.15 m from the reference point on the left-right and up-down axis shall
deviate by not more than 2 dB from the sound pressure level at the reference point.
(4) With the test subject and the subject’s seat absent, the difference of the sound pressure levels
produced by the loudspeaker at points on the reference axis 0.10 m in front of and 0.10 m behind the
reference point shall deviate from the theoretical value given by the inverse square law by no more
than 1 dB for any of the test signals.
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(5) In order to test at 0 dB HL in a sound field using the RETSPLS shown in Table 9, the ambient
noise in the sound field shall not exceed the maximum ambient permissible sound pressure levels
listed in ANSI/ASA S3.1.
RETSPL values in a sound field are dependent upon the angle of incidence of the sound source and
upon listening conditions. Table 9 gives RETSPL values for binaural and diffuse field listening at 0, 45,
and 90 degrees of incidence.
Table 9 — Reference equivalent threshold sound pressure levels (RETSPLs) (dB re 20 Pa) for
sound-field testing
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10.1 Marking
The audiometer shall be marked to show its type (subclause 4.1), the name of the manufacturer, the
model designation, the serial number, and the transducers to be used with the instrument. Labeling
should also include notation as to the country of origin and the safety standards met (subclause 5.1).
An instruction manual that includes full operating instructions and the information below shall be
supplied with the audiometer.
1) The type of audiometer and a description of the facilities provided (clause 4).
2) The applicable safety standards and the labeling requirements as specified in those standards
(subclause 5.1).
4) The permissible power supply variation and environmental conditions to ensure conformity
(subclauses 5.3.1 and 5.3.2).
5) The limits of battery voltages within which a battery-operated audiometer meets its
specifications (subclause 5.3.3).
6) The test frequencies at which bone-conduction thresholds obtained in an unoccluded ear may
be invalidated by radiated air conduction sound pressure levels attributable to nonlinearity of the bone
vibrator (subclause 5.4.3).
7) A description of the correct manner of installing the audiometer for normal use in order to
minimize the effect of unwanted sound radiation (subclause 5.4.4).
8) The range of frequencies and hearing levels for each transducer provided (subclause 6.1.1).
10) The manufacturer shall specify how conformity with this standard can be achieved using
loudspeakers or other components not provided with the audiometer by the manufacturer. The
manufacturer shall state for signal input or output connections the frequency response, the
impedance, and voltage for stated conditions required to achieve conformity with this standard
(subclause 6.2.4, 6.2.6, 6.2.7, 6.2.8, 6.2.9).
11) The bone vibrator output, the frequency response, and tolerances in the range from 250 to 4000
Hz (subclause 6.2.6).
14) The spectrum, reference level, and masking effect of each masking sound provided (subclauses
6.3 and 7.4).
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15) The resolution and rate of change of the hearing level control for Békésy or automatic recording
audiometers, and specification of the rate of change of the frequency for audiometers providing
continuously variable frequency (subclauses 7.3.2 and 6.1.2, respectively).
16) The duration of the time interval during which the patient may respond and the algorithm
governing the test procedure (subclause 7.5.5).
17) Identification of the transducers and their RETSPLs. The origins of reference levels other than
from ANSI shall be stated together with the coupler and procedures used for calibration. The static
force obtained with the transducer headbands provided shall also be stated (subclauses 9.1.1 and
9.4.2).
18) The site of application (whether mastoid or forehead) for the bone vibrator, if provided, and a
statement as to whether the calibration applies to an unoccluded or occluded test ear, see ANSI
S3.13-1987 (subclause 9.4.3).
19) The sensitivities and nominal impedances of all input facilities; the available voltages and
nominal impedances of all output facilities; and the pin assignment of all external plug connectors.
20) The sound attenuation characteristics of the earphones with their cushions or enclosures in
place.
21) EMC warning: a warning should be given as to the likely effects of radiated electromagnetic
fields, particularly those from high powered (EMC radiating) medical devices on the performance of
the audiometer.
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Annex A
(normative)
The difference between the free-field equivalent sensitivity level (Gf) and the coupler sensitivity level
(Gc) for two types of audiometric earphones using one-third octave bands of noise as test signals are
given in Table A.1 as a function of center frequency. The data were obtained under binaural listening
conditions, but the results are equally applicable for monaural speech audiometry. These figures have
to be added to measured data of sound pressure levels produced by an earphone of given type in an
acoustic coupler or ear simulator in order to obtain the equivalent free-field sound pressure levels
produced by the respective earphone.
Telephonics TDH 39 and TDH 49/50 earphones shall be used with MX 41/AR (or model PN 51)
cushions on the human ear, on the acoustic coupler, and on the ear simulator. The earphones shall be
applied with a nominal static force of 4.5N ± 0.5N.
[A.2] IEC 60645-2: Electroacoustics – Audiometers – Part 2: Equipment for speech audiometry.
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Table A.1 — Difference between the free-field equivalent sensitivity level GF and the coupler or
acoustic coupler or ear simulator level GC for two types of earphones
GF-GC (dB)d
Sennheiser HDA
Center Telephonics TDH 39 Telephonics TDH 49/50
200
frequency
IEC 60318-2 with
(Hz) IEC 60318a ANSI 9Ab IEC 60318a ANSI 9Ab
flat plate adapter
125 -16 -17.5 -19 -21 -5
c
160 -14 -14.5 -17 -18 -4.5
c
200 -12 -12 -14.5 -15 -4.5
250 -10 -9.5 -12 -12 -4.5
c
315 -7 -6.5 -9 -8 -5
400 -4 -3.5 -5.5 -4.5 -5.5
500 -1.5 -0.5 -2.5 -1 -2.5
c
630 -0.5 0 -1 0 -2.5
c
800 -1 -0.5 -2 -1 -3
1000 -1.5 -0.5 -3 -2 -3.5
1250 -1.5 -1 -2 -1.5 -2
1600 -5 -4 -6.5 -5.5 -5.5
2000 -7 -6 -9 -7.5 -5
2500 -7.5 -7 -10.5 -8 -6
3150 -10.5 -10.5 -12.5 -9 -7
4000 -11.5 -10.5 -13.5 -9.5 -13
5000 -7.5 -11 -8.5 -8.5 -14.5
6300 -17 -10.5 -12 -10.5 -11
8000 -6.5 1.5 -7.5 -5 -8.5
a IEC 60318-1, -3, Electroacoustics – Simulators of the human head and ear (all parts).
b ANSI/ASA S3.7 American National Standard Method for Coupler Calibration of Earphones.
c These values are derived by interpolation.
d Values rounded to the nearest half decibel.
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Annex B
(normative)
B.1 The frequency response of recordings used with speech audiometers shall have a frequency
response of ± 1 dB over the frequency range of 250 to 4000 Hz, and ± 2 dB outside this range but
within the range from 125 to 8000 Hz.
B.2 Recordings for use with speech audiometers shall include a preliminary signal of 1000 Hz or a
noise having characteristics as described in subclause 6.3.3 at the same level as the speech material
on the recording. This signal permits the amplification of the speech audiometer to be adjusted readily
to the zero reference on the monitor meter for the purpose of calibrating the sound output levels.
B.3 For the assessment of the speech recognition threshold level the recorded speech material shall
be spondee words, although this rule does not preclude the use of other speech material for more
extensive tests or other purposes.
B.4 Recordings for testing the frequency response of the speech audiometer including the playback
equipment and the recording shall contain signals that have a duration of not less than 15 s and shall
consist of one-third octave bands of white noise centered at one-third octave frequencies in the
frequency range 125 to 8000 Hz.
B.5 Signal-to-noise ratio of 40 dB. The level of any inherent background noise on the recording shall
be at least 40 dB below the level of the calibration signal as measured with frequency weighting C and
time weighting F.
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Annex C
(normative)
C.1 General
This annex specifies interim reference threshold values for two types of earphones, and describes two
coupler adapters for use with the IEC 60318-1 ear simulator for the calibration of these earphones for
use at frequencies up to 16000 Hz.
C.2 Calibration
Calibration shall be performed using an IEC 60318-1 ear simulator and appropriate flat plate adapter.
During calibration the earphone shall be applied to the adapter with a static force between 9 and 10 N.
C.3 Microphone
The microphone in the IEC 60318-1 ear simulator shall conform to the mechanical configuration of
Type WS2P microphone (IEC 61094-4) and shall be used without its protective grid. If a protective grid
is used, correction values for the difference in measurements conducted with and without the grid shall
be stated.
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Figure C.1 — Type 1 adapter for use with IEC 60318-1 ear simulator
Figure C.2 — Position of Type 1 adapter on the IEC 60318-1 ear simulator
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Figure C.3 — Type 2 adapter for use with IEC 60318-1 ear simulator
Figure C.4 — Position of Type 2 adapter on the IEC 60318-1 ear simulator
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Temperature: 18 °C to 26 °C.
C.8 References
[C.1] IEC 60318-1:2009, Electroacoustics - Simulators of human head and ear - Part 1: Ear
simulator for the measurement of supra-aural and circumaural earphones
[C.3] ISO 389-5:2006, Acoustics – Reference zero for the calibration of audiometric equipment –
Part 5: Reference equivalent threshold sound pressure levels for pure tones in the frequency range 8
kHz to 16 kHz.
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Annex D
(informative)
D.1 General
Three methods are commonly used for the transfer of reference equivalent threshold values from a
standard reference earphone to an earphone of a different type. These are the probe-tube method
(clause D.2), the loudness-balance method (clause D.3), and the threshold-determination method
(clause D.4). The transfer of reference equivalent threshold values should be carried out with no fewer
than six otologically normal subjects whose hearing threshold levels are no poorer than 10 dB HL at
each audiometric frequency. At least three examples of an earphone of a new design shall be
evaluated electroacoustically to ensure that the example chosen is representative of the type. The
level of the test signal shall be adjustable in increments no greater than 2.5 dB. The attenuation of
ambient noise by the earphone with its cushion or enclosure in place shall be established as described
in ANSI/ASA S12.6 Method A, and the results used to calculate allowable levels of background noise
for that earphone in accordance with ANSI/ASA S3.1. If the new earphone and its cushion do not
permit calibration on the IEC 60318-1 ear simulator or the NBS 9-A Coupler/IEC 60318-3 acoustic
coupler, appropriate calibration procedures should be developed and described.
1) A probe-tube microphone is mounted so that the tip of the probe is fixed in position at the
entrance to the ear canal of a human subject. In effect, the subject’s ear serves as an acoustic
coupler.
2) A standard reference earphone is mounted on or around the ear of the subject, as appropriate.
Care must be taken not to disturb the position of the tube of the probe microphone with the earphone
cushion which now overlies it.
3) A sine wave generator or audiometer is used to drive the earphone. Pure tone signals of a
specified sound pressure level, as measured by the probe microphone, are generated at each
audiometric test frequency, and the corresponding signal voltages measured across the terminals of
the earphone are recorded. It is suggested that the sound pressure level of the tones should not
exceed 80 dB. The validity of the voltage measurements and possibly the integrity of the generator are
dependent upon the observation of good measurement practice. A voltage measuring instrument with
a differential input configuration is preferred.
5) The standard reference earphone is placed on a standard acoustic coupler or ear simulator, the
terminal voltages recorded in Step 3 are reproduced, and the sound pressure levels of the resulting
signals are recorded.
6) Step 5 is repeated with the non-standard earphone mounted on a specified standard acoustic
coupler or ear simulator. This coupler may or may not be the same as that used with the standard
reference earphone.
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7) The sound pressure levels developed in the couplers are then used to transfer the reference
equivalent threshold values of the standard reference earphone to the test earphone and specified
coupler or ear simulator.
NOTE This method is described in Corliss, E. L. R. and Burkhard, M. D. A Probe Tube Method for Transfer of
Threshold Standards between Audiometric Earphones, J. Acoust. Soc. Am., Vol. 55, 1953, 990-1003.
References:
Barry, S. J. and Vaughn, R. B. Loudness balance calibration of bone conduction vibrators, J. Speech
Hear. Res., 1981, 24: 454-459.
Harris, J. D. Efficient monaural procedure for the psychoacoustic calibration of earphones, J. Acoust.
Soc. Am., 1970, 47: 1048-1054.
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1) Details of a standard calibration procedure, including the coupler or adapter, or both, used;
2) Details of the method used to determine the new reference equivalent threshold levels;
3) Reference equivalent threshold values of the standard reference earphone calibrated in the ear
simulator or acoustic coupler used;
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Annex E
(informative)
Audiogram format
E.1 General
Each audiogram form should have spaces where the following may be noted: name, age, gender, test
site, and the number of the test subject; time and date of the test; the manufacturer’s name; type and
serial number of the audiometer; and tester’s name. The results of hearing threshold measurements
may be recorded as a numerical tabulation or in the graphic form of an audiogram.
For sweep frequency automatic audiograms it is recommended that one octave on the frequency
scale be linearly equivalent to the length of 30 dB on the hearing level scale.
For extended high frequency audiograms it is recommended that 1/6 of an octave on the frequency
scale be linearly equivalent to the length of 10 dB along the hearing level scale.
When presenting the test results graphically in an audiogram covering the range from 125 to 16000 Hz
the format specified in ISO 8253-1:1989 clause 10 shall be used.
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Annex F
(informative)
NOTES
1 Base material; Buna-S rubber
2 Cap material; sponge neoprene
3 Base and cap shall be securely bonded together by use of suitable cement
4 Durometer readings (Shore A): 20 ± 5 for the front cap; 40 ± 5 for the back base
5 Finished cushion should withstand, without appreciable deterioration, an oxygen bomb test at a pressure of
300 psi and a temperature of 70 degrees C for 48 h
6 Dimension of the base may be modified to adapt to a chosen earphone
7 All dimensions are in inches
8 Tolerance 1/64 inch
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NOTES
1 Material is synthetic rubber compound MIL-R-3065 class SC312F
2 Durometer is 30 ± 5 (Shore A)
3 Clean with alcohol or soap and water
4 Material is resistant to tear, compression set, abrasion, flex cracking, skin oils, oxidation, ozone, sunlight
aging, acids, and alcohols
5 All dimensions are in inches
References:
Michael, P. & Bienvenue, G. R. (1980). A comparison of acoustical performance between a new one-
piece earphone and the conventional two-piece MX-41/AR cushion. J. Acoust. Soc. Am. 67, 693-698.
Michael, P. & Bienvenue, G. R. (1981). Noise attenuation characteristics for supra-aural audiometric
headset using the MX-41/AR and the Telephonics Model 51 cushion. J. Acoust. Soc. Am. 70, 1235-
1238.
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Annex G
(informative)
2) When a specified usage (operating hours) has elapsed. This is based on usage and
environment, requested by the audiometer’s owner. Typically this is an interval of a 3- or
6-month period, based on instrument usage.
Functional inspection, performance checks, and bioacoustic checks should be conducted daily to
verify the equipment performance before use.
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The purpose of routine checking is to ensure that the equipment is working properly, that its calibration
has not noticeably changed, and that its transducers and connections are free from any defect that
might adversely affect the test result. The most important elements in daily performance checks are
the subjective tests and these tests can only be successfully carried out by an operator with
unimpaired and preferably known good hearing. If a booth or separate test room is used, the
equipment should be checked as installed; an assistant may be required in order to carry out the
procedures. The checks will then cover the inter-connections between the audiometer and the
equipment in the booth, and all connecting leads, plugs, and socket connections at the junction box
(sound room wall) should be examined as potential sources of intermittency or incorrect connection.
The ambient noise conditions during the tests should not be substantially worse than those
encountered when the equipment is in use.
Check earphone cushions, plugs, main cord, and accessory cords for signs of wear or damage.
Switch on equipment and leave for the recommended warm-up time. Carry out any set-up adjustments
as specified by the manufacturer. On battery-powered equipment, check battery state using the
manufacturer’s specified method.
Check that earphone and bone vibrator serial numbers are correct for use with the audiometer.
Check that audiometer output is approximately correct on both air and bone conduction by conducting
a simplified audiogram on a known test subject with known hearing; check for any change.
Check at high level (for example hearing levels of 60 dB on air conduction and 40 dB on bone
conduction) on all appropriate functions (and on both earphones) at all frequencies used; listen for
proper functioning, absence of distortion, freedom from clicks, etc.
Check all earphones (including masking transducer) and the bone vibrator for absence of distortion
and intermittency; check plugs and leads for intermittency.
Check that all switch knobs are secure and that indicators work correctly.
Listen at low levels for any sign of noise, hum, or unwanted sounds.
Check that attenuators do attenuate the signals over their full range and that attenuators which are
intended to be operated while a tone is being delivered are free from electrical or mechanical noise.
Check that controls operate silently and that no noise radiated from the audiometer is audible at the
subject’s position.
In addition to the checks given in G.2.2, periodic objective electroacoustic checks consist of measuring
and comparing results with applicable sections of ANSI/ASA S3.6. After the audiometric equipment
has been submitted for periodic objective check, a calibration certificate showing the values recorded
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must be filled out, signed, and dated by the technician, demonstrating that the audiometer conforms to
requirements in this clause G.2.3.
Pure tone output levels (air conduction and bone conduction transducers) - Measured and recorded as
deviation from standard.
Speech output level - Signal applied to input, VU meter at zero (air conduction and bone conduction
transducers) - Measured and recorded as deviation from standard.
Masking noise level (air conduction and bone conduction transducers) - Measured and recorded as
deviation from standard.
Attenuator step accuracy (limited range, 0-60 dB HL) - Check higher levels via biological listening
check.
NOTE It is considered good practice to perform annual checks of the audiometric test room’s noise level as
part of annual calibration using the applicable table per ANSI/ASA S3.1 American National Standard Maximum
Permissible Ambient Noise Levels for Audiometric Test Rooms to ensure that audiometer performance will not be
affected by any changes in the audiometric test room’s noise levels.
Visual inspection, safety - Check power cord and accessory cords for signs of wear or damage and
general physical condition of instrument.
Headband – Tension.
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Linearity of all channels (all transducers) (dB) - Recorded as a deviation from standard.
Interrupter switch
Switch sounds
Mechanical sounds
Narrow band noise output level - Measured and recorded as deviation from standard, all transducers.
White noise output level - Measured and recorded as deviation from standard, all transducers.
Speech output level - Signal applied to input, VU meter at zero - Measured and recorded as deviation
from standard, all transducers.
Speech through external inputs - CD / tape / phono - VU meter at zero - Measured and recorded as
deviation from standard all transducers.
Warble/FM output level - Actual measurement recorded (all frequencies) as deviation from standard.
Speech inputs in sound field output level - Signal applied to input, VU meter set at zero - Measured
and recorded as deviation from standard.
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Narrow band noise output level - Measured and recorded as deviation from standard, all transducers.
Speech/white noise output level - Measured and recorded as deviation from standard, all transducers.
NOTE Operation of instrument should be checked for normal function post calibration.
2) Mechanical Coupler (used for bone conduction calibration) – B&K 4930 Artificial Mastoid – or
other mechanical coupler. Must meet ANSI S3.13.
3) System to measure:
Frequency
Rise time
Fall time
Duration
Over shoot
5) Acoustic Coupler – NBS–9A (6cc) ANSI/ASA S3.7, or IEC 60318-3, Part 3: Electroacoustics –
Simulators of human head and ear – Part 3: Acoustic coupler for the calibration of supra-aural
earphones used in audiometry.
Ear Simulator ANSI/ASA S3.7 or IEC 60318-1, Part 1: Electroacoustics - Simulators of human
head and ear - Part 1: Ear simulator for the measurement of supra-aural and circumaural
earphones
Ear simulator ANSI/ASA S3.25 - IEC 60318-4, Part 4: Occluded-ear simulator for the
measurement of earphone coupled to the ear by means of ear inserts (revision of IEC
60711:1981).
6) Specification / calibration information for all microphones, filters, SLM, and couplers showing
correction values needed to be applied to maintain accuracy.
8) Calibration reports/sheets that demonstrate the audiometer meets the requirements and
records the measurement results of the calibration.
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Bibliography
[1] Scharf, B. Critical band. Foundations of modern auditory theory. (Ed. Tobias, J.V.) Vol. 1,
Academic Press, New York, 1970.
[2] Zwicker, E. and Terhardt, E. Analytical expressions for critical-band rate and critical band-width
as a function of frequency. J. Acoust. Soc. Amer., 68(5), 1980, pp. 1523-1525.
[3] ANSI/ASA S3.2-2009 American National Standard Method for Measuring the Intelligibility of
Speech over Communication Systems.
[4] ANSI/ASA S3.21 American National Standard Method for Manual Pure-Tone Threshold
Audiometry.
[5] ANSI/ASA S12.6 American National Standard Methods for Measuring the Real-Ear Attenuation
of Hearing Protectors.
[7] ISO 8253-1:1989 Acoustics – Audiometric test methods – Part 1: Basic pure-tone air and
bone-conduction threshold audiometry.
[8] ISO 8253-2 Acoustics – Audiometric test methods – Part 2: Sound-field audiometry with pure-
tone and narrow-band test signals.
[9] ISO 8253-3 Acoustics – Audiometric test methods – Part 3: Speech audiometry.
[11] Frank, T. & Holmes, A. E. (1981). Acoustic Radiation from Bone Vibrators, Ear and Hearing
2(2), 59-63.
[12] Frank, T. & Richards, W. D. (1991). Hearing Aid Coupler Output Level Variability and Coupler
Correction Levels for Insert Earphones, Ear and Hearing 12(3), 221-227.
[13] Killion, M. C. (1978). Revised Estimate of Minimum Audible Pressure. Where is the Missing 6
dB?, J. Acoust. Soc. Am. 63, 15011508.
[14] Shaw, E. A. G. & Vaillancourt, M. M. (1985). Transformation of Sound Pressure Level from the
Free Field to the Eardrum Presented in Numerical Form, J. Acoust. Soc. Am. 78, 112023.
[15] Lutman, M.E. and Qasem, H.Y.N. A source of notches at 6 kHz. /In/ Prasher, D. and Luxon, L.
/ed. Advances on Noise Research Volume 1 Biological Effects of Noise/, London, Whurr, 1998, 170-
176.
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MEMBERS OF THE ASA COMMITTEE ON STANDARDS (ASACOS)
P.D. Schomer, Chair and Representation S1, Acoustics ASA Technical Committee
ASA Standards Director Representation
P. Battenberg, Chair, S1
Schomer and Associates A.P. Lyons, Acoustical
R.J. Peppin, Vice Chair, S1
2117 Robert Drive Oceanography
Champaign, IL 61821 A.H. Marsh, ASA Representative, S1
Tel: +1 217 359 6602 A.E. Bowles, Animal Bioacoustics
Fax: +1 217 359 3303 P.D. Schomer, ASA Alternate
A. Campanella, Architectural
Representative, S1
Acoustics
Representation S2, Mechanical P.J. Kaczkowski and V. Khokhlova,
Vibration and Shock Biomedical Ultrasound/
Bioresponse to Vibration
R.D. Hellweg, Jr., Vice Chair A.T. Herfat, Chair, S2
R.M. Drake, Engineering Acoustics
Hellweg Acoustics C.F. Gaumond, Vice Chair, S2
13 Pine Tree Road ASA Representative, S2 D. Deutsch, Musical Acoustics
Wellesley, MA 02482
B.E. Douglas, ASA Alternate R.J. Peppin, Noise
Tel: +1 781 431 9176
Representative, S2
R. Raspet, Physical Acoustics
Representation S3, Bioacoustics J. DiGiovanni, Psychological and
C.A. Champlin, Chair, S3 Physiological Acoustics
S.B. Blaeser, Standards Manager ASA Representative, S3 C.F. Gaumond, Signal Processing in
G.J. Frye, Vice Chair, S3 Acoustics
Standards Secretariat
Acoustical Society of America M.D. Burkhard, ASA Alternate S. Narayanan, Speech
35 Pinelawn Rd., Suite 114E Representative, S3 Communication
Melville, NY 11747 D. Capone, Structural Acoustics and
Tel: +1 631 390 0215 Representation S3/SC1, Animal Vibration
Fax: +1 631 390 0217 Bioacoustics
Email: asastds@aip.org R.M. Drake, Underwater Acoustics
D.K. Delaney, Chair, S3/SC1
M.C. Hastings, Vice Chair, S3/SC1
ASA Representative, S3
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ANSI/ASA S3.6-2010
(a revision of ANSI S3.6-2004)
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