User Guide

 echargeable self-fitting OTC hearing aids

R
CRE-E10
 WARNING
If you are younger than 18, do not use this.
You should go to a doctor, preferably an ear-nose-throat
doctor (an ENT), because your condition needs specialized
care. Over-the-counter hearing aids are only for users who
are 18 or older.
This OTC hearing aid is for users who are 18 and older.
People who are younger than 18 with hearing loss should see
a doctor, preferably an ENT, because they may need medical
testing and management. Hearing loss can affect speech and
learning, so professional fitting and continuing care are also
important.

2
WARNING
When to see a doctor.
If you have any of the problems listed below, please see a
doctor, preferably an ear-nose-throat doctor (an ENT).
X Your ear has a birth defect or an unusal shape. Your ear
was injured or deformed in an accident.
X You saw blood, pus, or fluid coming out of your ear in the
past 6 months.
X Your ear feels painful or uncomfortable.
X You have a lot of ear wax, or you think something could be
in your ear.
X You get really dizzy or have a feeling of spinning or
swaying (called vertigo).
X Your hearing changed suddenly in the past 6 months.
3
 X Your hearing changes: it gets worse, then better again.
X You have worse hearing in one ear.
X You hear ringing or buzzing in only one ear.

4
WARNING
This hearing aid should not cause pain when inserting it.
Remove the device from your ear if it causes pain or
discomfort when you insert or place it. To try again, make
sure to follow the instructions. If you feel pain or discomfort
again, contact the manufacturer. If your pain or discomfort
does not go away, contact your hearing healthcare
professional. You can also report this to FDA as an adverse
event according to the instructions that appear later.

5
 WARNING
Risk of injury!
Always wear the hearing aid with a Click Sleeve.
X Make sure that the Click Sleeve is completely attached.
You should feel that it snaps into place.
X Ensure that only a single Click Sleeve is attached to each
hearing aid.
X In the very rare case that the click sleeve gets stuck in
the ear canal and you cannot remove it yourself, please
contact a physician.
X Do not insert the Click Sleeves in your ears without the
hearing aid attached.

6
WARNING
In case you have any doubt whether this device is
appropriate for you, consult a licensed physician before using
this device.

WARNING
This hearing aid is intended for you only and should not be
worn by others.

NOTICE
Do not use your hearing aids while swimming or while taking
a shower.

7
 WARNING
Choking hazard!
Your hearing aids contain small parts which can be
swallowed.
X Keep hearing aids, batteries and accessories out of reach
of children and pets.
X If parts have been swallowed consult a physician or
hospital immediately.

8
CAUTION
This is not hearing protection.
You should remove this device if you experience overly loud
sounds, whether short or long-lasting. If you’re in a loud
place, you should use the right kind of hearing protection
instead of wearing this device. In general, if you would use
ear plugs in a loud place, you should remove this device and
use ear plugs.

CAUTION
The sound output should not be uncomfortable or
painful.
You should turn down the volume or remove the device if
the sound output is uncomfortably loud or painful. If you
consistently need to turn the volume down, you may need to
further adjust your device.
9
 CAUTION
You might need medical help if a piece gets stuck in
your ear.
If any part of your hearing aid, like the eartip, gets stuck in
your ear, and you cannot easily remove it with your fingers,
get medical help as soon as you can. You should not try to
use tweezers or cotton swabs because they can push the
part farther into your ear, injuring your eardrum or ear canal,
possible seriously.

Note: If you remain concerned, consult a professional.

If you try this device and continue to struggle with or remain
concerned about your hearing, you should consult with a hearing
healthcare professional.

10
Note: What you might expect when you start using a hearing
aid.
A hearing aid can benefit many people with hearing loss. However,
you should know it will not restore normal hearing, and you may
still have some difficulty hearing over noise. Further, a hearing aid
will not prevent or improve a medical condition that causes hearing
loss.
People who start using hearing aids sometimes need a few weeks
to get used to them. Similarly, many people find that training or
counseling can help them get more out of their devices.
If you have hearing loss in both ears, you might get more out of
using hearing aids in both, especially in situations that make you
tired from listening - for example noisy environments.

11
Note: Tell FDA about injuries, malfunctions, or other adverse
events.
To report a problem involving your hearing aid, you should submit
information to FDA as soon as possible after the problem. FDA
calls them “adverse events”, and they might include: skin irritation
in your ear, injury from the device (like cuts or scratches, or burns
from an overheated battery), pieces of the device getting stuck in
your ear, suddenly worsening hearing loss from using the device,
etc.

Instructions for reporting are available at

https://www.fda.gov/Safety/MedWatch, call 1-800-FDA-1088.
You can also download a form to mail to FDA.

12
Content
Your hearing aids   19
Intended use   20
How to use QR codes   21
What you’ll find in the box   23
Get to know your hearing aids   24
Get to know your charger   25
Start here   26
Activate and charge before first use   29
Charging   29
Turning on and off   30
Inserting and removing the hearing aids   31
How to change Click Sleeves   36

 13
Charging   39
Charge devices while on the go   39
Charging via electrical outlet   40
Check charging status   41
Low power indication   44
Charging tips   45
How often do I need to charge the hearing aids?   45
How long does charging take?   45
What happens if I forgot to charge?   46
Switch off the hearing aids for long term storage   46
Charging your hearing aids   48
Requirements for the USB power adapter   51
Sony | Hearing Control app   52

14 
Daily use   54
Adjusting the volume   54
Audio streaming with iPhone   55
Airplane mode for hearing aids   56
Adjusting your hearing aid   57
What to do in loud environments   58
Explosive atmospheres   60
Possible physiological side effects   61
Exposure to nickel   62
Cleaning and maintenance   63
Troubleshooting for hearing aids and charger   70
Technical information   75
Clinical data   78
Human factors data   78
 15
 Damaged devices, unauthorized changes   79
Restricted areas for wireless devices   81
Interference by strong radiation   82
Explanation of symbols   84
Important information   88
Operating, transport and storage conditions   88
Disposal information   92
Conformance information   92
Regulatory information   95
For hearing aid users   96
Quality of Service (QoS) for the ear-to-ear wireless
technology   107
Cybersecurity   109
For children with hearing loss   110

16 
Country/region specific information   111
Conformance information for charger   112
Support   113

 17
 NOTICE
X The left and the right hearing aid are intended to be worn
together. They operate as a set.

CAUTION
Read this user guide thoroughly and completely to avoid
damage and injury.

18
Your hearing aids
A power cell (lithium-ion rechargeable battery) is permanently
built into your hearing aid. This enables easy charging with your
charger.
The wireless functionality enables advanced audiological features
and synchronization between your two hearing aids.
Your hearing aids feature Bluetooth® Low Energy* technology
allowing for easy data exchange with your smartphone, and for
seamless audio streaming with your iPhone**.

* The Bluetooth word mark and logos are owned by the Bluetooth SIG, Inc., and any use of such
marks by Sony Corporation is under license. Other trademarks and trade names are those of their
respective owners.
** Apple, the Apple logo, iPhone, iPad, and iPod are trademarks of Apple Inc., registered in the U.S.
and other countries and regions.

19
Intended use
The self-fitting hearing aid is intended to amplify sound for
individuals 18 years of age or older with perceived mild to moderate
hearing impairment. It is adjusted by the user to meet the user’s
hearing needs through software tools. The device is intended for
direct-to-consumer sale and use without the assistance of a hearing
care professional.
The charger is intended to charge our specific hearing aids with
built‑in power cells (lithium‑ion rechargeable batteries).
The Sony | Hearing Control app is intended to support self-fitting
and fine-tuning of the hearing aid.

20
How to use QR codes
You will find QR codes* throughout the user guide. These QR
codes will help you to install the Sony | Hearing Control app or to
view instructional videos.
Start now by scanning the QR code with your smartphone camera
or by typing the URL into your browser:
1. Open the QR Code reader or smartphone camera on your
phone.
2. Hold your device over the QR Code so that the QR code is
clearly visible within your smartphone’s screen.
3. The phone will automatically scan the QR code. When your
smartphone reads the QR code, a link will appear. Click the link
to go to the video.

* QR Code is registered trademark of DENSO WAVE INCORPORATED.

21
 NOTICE
X Not all smartphone readers work the same. Some may
require additional steps.

22
What you’ll find in the box

Left and right hearing aid,

Charger + USB cable
Click Sleeve S attached.

Click Sleeves
Cleaning brush Cleaning cloth
sizes XS, M, and L
X Quick start card and user guide
X Limited warranty

23
Get to know your hearing aids
➊

➌
➍
➋

➊ Click Sleeve ➌ Side indicator

➋ Microphone openings (R = right ear, L = left ear)
➍ Charging contacts
You can use the following standard Click Sleeves:
Click Sleeve closed (standard)

Click Sleeve vented (optional)

24
Get to know your charger
➊
➌ ➐
➋ ➏

➌ ➌
➍ ➎ ➍ ➎

➊ Lid ➎ Push button

➋ Charging cups ➏ USB power port
➌ LEDs – hearing aids ➐ USB power cable
➍ LED – charger

25
 Fully charge your hearing aids before using them for the first
time.

Start here
It is required to complete all steps in the Sony | Hearing Control app
to setup the hearing aids for your needs.
You will be guided through the process. It will take around 10
minutes.
Before starting the process, please do the following:
X Ensure strong internet access (Wi-Fi or cellular) throughout the
customization process
X Find a place where you are not disturbed by other loud sounds

26
X Unmute your smartphone and disable silent mode
X Set the volume for media sounds of your smartphone to a high
level (about 75%).

27
Download the Sony | Hearing Control app to personalize your
hearing aids.

sony.net/hearing-e10-app

Follow the Sony | Hearing Control app for instructions.

28
Activate and charge before first use

Charging
Connect the charger and a suitable
power adapter (not included) with
the USB cable. Use the cable which
came with the device.

➊ ➋

Keep the hearing aids inside the

charger.

29
While charging, the lights are pulsing
orange. Your hearing aids are now
activated. The lights change to constant
green when the batteries are fully charged

Turning on and off

There is no on/off button on the hearing aids.

X Turning on: Take the hearing aids out of the charger.

X Turning off: Place the hearing aids in the charger.

30
Inserting and removing the hearing aids
Inserting a hearing aid:
X Identify right and left hearing aid so
that you insert it in the correct ear.
Letters R and L indicate the side:
R = right ear
L = left ear

31
X Make sure the Click Sleeve is positioned correctly.
The shape should follow the shape of the hearing aid.
Turn the Click Sleeve so the little tab is on the outside.

32
X Hold the hearing aid correctly before inserting it.

NOTICE
X Push the device into the intended position, making sure
there is no discomfort/resistance.

33
X Place the hearing aid in the
outer ear and twist it slightly
until it sits well.

WATCH QUICK VIDEO TUTORIAL

sony.net/hearing-e10-insertion

34
 If you have problems inserting the hearing aid, use the other
hand to gently pull your earlobe downwards. This opens the
ear canal and eases insertion of the hearing aid.
Removing a hearing aid:
X Grip the hearing aid with
two fingers and pull it out.

35
Clean and dry your hearing aids after usage. Read more in the
Safety and maintenance information.

How to change Click Sleeves

The hearing aids come with the size S Click Sleeves pre-attached.
If you do not feel comfortable using this size, you can change the
Click Sleeves.
Please note mind that left and right ear sizes may differ.

36
Choose a smaller size if the hearing aid
feels tight in your ear.
Choose a larger size if the hearing aid
feels loose or makes whistling noise.

Removing Click Sleeve

Pinch and pull off the Click Sleeve.
Click Sleeves are designed to be
discarded after removal from device.
Installing new Click Sleeve
Make sure that the little tab of the
Click Sleeve is on the outside of
the hearing aid. You will hear a click
when it is fully installed. *Shown for the left device

37
 NOTICE
Select the Click Sleeve size that gives you the best wearing
comfort in each ear. Left and right ear sizes may differ.
Choose a larger size in case of whistling problems.

38
Charging

Charge devices while on the go

When fully charged, the charging base holds two portable charges
for on the go convenience.

Charging hearing aids

X Place the right hearing aid in the
charging cup marked with an “R”,
and the left hearing aid in the
charging cup marked with an “L”.
X Close the charger’s lid.

39
X The hearing aids are automatically turned off and start charging.
The charging status is shown for 7 seconds.
X LED indicators pulsing orange: hearing aids are charging.
If not: see the Troubleshooting section.

Charging via electrical outlet

X Connect the charger to the
power adapter and plug it into an
electrical outlet.
X Or place the charger on a wireless
Qi-charger.
X The internal battery of the charger is charged.
X Put the hearing aids in the charger to also
charge the hearing aids.

40
X The LEDs start pulsing orange to indicate that the hearing aids
and the charger are being charged. If not: see troubleshooting
section.
X When the charger is plugged into the wall, constant-on green
LEDs indicate that charging is completed.
X For wireless Qi charging, the LEDs will turn off when charging is
completed.

Check charging status

● The hearing aids are in the charger.
Disconnect the charger from the electrical outlet.
● Check the charging status of the hearing aids and the charger
either
- by opening the lid, or
- by briefly pressing the button
41
If the status LED does not light up when you press the button,
check the following:
● The charger is off. Press and hold the button for 5 seconds to
turn on the charger.
● The charger’s internal battery is too low to display the status.
Connect the charger to an electrical outlet, wait several minutes
and try again.
LED Behavior of LED lights when using portable charging
Solid green
Internal battery has enough capacity to fully charge two
hearing aids.
Solid orange
Internal battery does not have enough capacity to fully
charge two hearing aids.

42
LED Behavior of LED lights when using portable charging
Blinking orange
Internal charger battery empty. Charging of hearing
aids is not possible.

LED Hearing aid LED

Pulsing orange
Hearing aid is being charged.
Solid green
Hearing aid is fully charged.
LED is off
No hearing aid is in the charger, hearing aid is not
placed correctly, or charger is off.

43
 LED Hearing aid LED
Blinking twice orange
Cooling phase. Charging is resumed when the device
has cooled down. Refer to section "Troubleshooting for
hearing aids and charger".
Blinking red
Hearing aid error. Refer to section "Troubleshooting for
hearing aids and charger".

Low power indication

An audible alert signal to indicate the hearing aid power cell is
running low will be played. The signal will be repeated every 20
minutes. Depending on the usage of your hearing aids, you have
approximately 1.5 hours to charge your hearing aids before they
stop working.
44
Charging tips
You may have some questions on how to best charge your
hearing aids. Read the questions and answers below. For further
information, visit https://www.sony.net/hearing-e10.

How often do I need to charge the hearing aids?

Hearing aids are meant to be charged daily, even if the power cell
is not empty. Charge them overnight so you can be sure to start
your day with fully charged hearing aids.

How long does charging take?

A full charging cycle takes approximately 4 hours (+/- 10 mins).
After 30 minutes, it is possible to use your hearing aids for up to 6
hours. Charging times may vary due to the use of the hearing aids
and the age of the power cell.
45
What happens if I forgot to charge?
Your hearing aids will automatically switch off when the power cell
is empty. Charge the hearing aids as soon as possible.
Hearing aids which have not been charged for over 6 months may
be damaged due to an unrecoverable deep-discharge of the power
cell. Deep‑discharged power cells cannot be charged anymore and
have to be replaced.

Switch off the hearing aids for long term storage

X Put the hearing aids in the charger and close the lid.
X Disconnect the charger from the electrical outlet.
X Press and hold the button for 5 seconds to turn the charger and
the hearing aids off.
X The LEDs light up green and fade out.

46
X To turn on the hearing aids and the charger again:
- press the button for 5 seconds, or
- connect the charger to an electrical outlet, or
- put the charger on a wireless Qi-charger.
X Keep the hearing aids inside the charger.

47
Charging your hearing aids

Safety information on lithium-ion rechargeable batteries

WARNING
A lithium-ion rechargeable battery is permanently built into
your device. Incorrect use of the device can cause the
lithium-ion rechargeable battery to burst.
Risk of injury, fire or explosion!
X Follow the safety instructions for lithium-ion rechargeable
battery in this section.

48
 WARNING
X Charge your hearing aids only with the approved charger.
X Immediately discontinue use if the hearing aids or the
charger feel hot.
X Do not dispose of the device in fire or water.
X Keep the device away from combustible materials, due
to the unlikely event of a lithium-ion battery bursting or
exploding.
In any of the above cases, contact the customer service for help.

49
 NOTICE
X To avoid environmental pollution, do not throw batteries or
hearing aids into household trash.
X Recycle or dispose hearing aids, accessories, batteries
and packaging according to local regulations.

WARNING
Risk of burns!
X Do not place anything other than your hearing aids in the
charger.

50
Requirements for the USB power adapter

WARNING
Risk of electric shock!
X Connect the charger only with a USB power
supply which complies with IEC 60950-1 and/or IEC
62368-1.

NOTICE
Use of incompatible parts poses a risk of malfunction.
X Use standard USB power adapter which supports an output
voltage of 5 V DC and an output current of 0.5 to 1 A.
X Use only the USB cable that is provided with the device.
X Do not insert incompatible connectors or foreign objects
into the charger port.
51
Sony | Hearing Control app

The Sony | Hearing Control app supports you with the following:
X Creating an account and signing in
X Pairing the hearing aids with the app
X Assessing your hearing profile
X Programming the hearing aids with your personalized settings
X Fine-tuning assistant
X For daily use: volume control, sound balance, and directivity

52
NOTICE
Set up the hearing aids in a quiet environment without
interruptions for the best result.

53
Daily use

Adjusting the volume

Your hearing aids automatically adjust the volume to the listening
situation.
X If you prefer manual volume adjustment, use the
Sony | Hearing Control app.
An optional signal can indicate the volume change.

54
Audio streaming with iPhone
Your hearing aids are Made for iPhone hearing aids. This means
you can get phone calls and listen to music from your iPhone
directly into your hearing aids.
For more information about compatible iOS devices, pairing, audio
streaming and other useful functions, consult the Sony CRE-E10
website or contact customer service.

“Made for iPhone”, “Made for iPad”, and

“Made for iPod” mean that an electronic accessory has been
designed to connect specifically to iPhone, iPad, or iPod,
respectively, and has been certified by the developer to meet
Apple performance standards. Apple is not responsible for the
operation of this device or its compliance with safety and regulatory
standards. Please note that the use of this accessory with iPhone,
iPad, or iPod may affect wireless performance. 55
Airplane mode for hearing aids
Airplane mode is when Bluetooth of your hearing aids is turned
off. In areas where the use of Bluetooth technology is not allowed
(e.g. on some airplanes), you can deactivate Bluetooth mode. This
turns Bluetooth in your hearing aids off temporarily. The hearing
aids still work without Bluetooth, however direct audio streaming
will not be possible and other functions will not be available.
X To deactivate or activate the Bluetooth mode, use the
Sony | Hearing Control app.
An alert tone indicates when Bluetooth mode is deactivated or
activated.

56
Adjusting your hearing aid
WARNING
Do not adjust the hearing aid when your attention is required
on other activities, for example when crossing a street or
driving a car.

WARNING
Your hearing devices may reduce certain background
sounds, potentially also traffic or warning signals. Adjust the
hearing aid to ensure you can hear surrounding sounds,
including alarms and warning signals. Be aware that it may
be more difficult to identify where a sound is coming from
during the first few weeks of use.

57
What to do in loud environments
WARNING
Do not use this device as hearing protection in loud
environments.

WARNING
Remove hearing aids before using hearing protection
equipment. Noise-cancelling headphones should not be used
as hearing protection.

58
WARNING
Frequent exposure to loud sounds may harm your hearing.
Keep the loudness at comfortable listening levels. Wear
hearing protection when exposed to loud environmental
noise.

NOTICE
The smartphone generates short tone sequences to control
the hearing aids. Do not hold the smartphone close to the ear
while using the app.

59
Explosive atmospheres
WARNING
Risk of explosion!
X Do not use your hearing aids in explosive atmospheres
(e. g. mining areas).

60
Possible physiological side effects
WARNING
In case of a known contact allergy, consult the customer
service regarding the presence of the allergen before using
the hearing aid. If an allergic reaction develops after wearing
the hearing aid, immediately discontinue use and consult a
licensed physician.

WARNING
Contact your physician if you experience any unusual skin
irritation, excessive accumulation of ear wax, dizziness,
change in your hearing, or if you think there might be an
object in your ear canal.

61
Exposure to nickel
WARNING
This product can expose you to nickel, which is known to the
State of California to cause cancer. For more information, go
to www.P65Warnings.ca.gov.

62
Cleaning and maintenance
Ear wax may accumulate in the Click Sleeves which may affect
sound quality.

NOTICE
X Clean your hearing aids daily with a soft and dry tissue.
Never use water. Only use cleaning products declared for
use with hearing aids.

NOTICE
X Protect your hearing aids from high humidity. Do not wear
them in the shower or when you apply make-up, perfume,
aftershave, hairspray or suntan lotion.

63
 NOTICE
X Protect your hearing aids from extreme heat. Do not store
them in direct sunlight.

NOTICE
X Do not dry your hearing aids in the microwave oven.

X Do not use alcoholic solvent on the charging contacts.

X To avoid corrosion, use a soft and dry tissue to wipe off sweat or
liquid from the charging contacts or hearing aids before inserting
them in the charger.
X Ask your customer service for recommended cleaning products,
special care sets, or more information on how to keep your
hearing aids in good condition.

64
NOTICE
X In the unlikely event corrosion becomes visible on the
surface of the charging contacts and cannot be wiped off,
discontinue wearing the device and contact your customer
service.

65
Storage
● Short-term storage (up to several days): Turn off your hearing
aids by placing them in the charger.
● The charger must be on. If the charger is not on and you place
your hearing aids in the charger, the hearing aids are not turned
off.
● Note that when you turn off the hearing aids via a remote
control or smartphone app, the hearing aids are not turned
off completely. They are in standby‑mode and still draw some
power.
● Long-term storage (weeks, months, ...):
First, fully charge your hearing aids. Leave them in the charger
with the lid closed. Once the hearing aids are fully charged the
charger and the hearing aids are turned off automatically.

66
X If you need to store your hearing aids for more than 3 months,
put them in the charger and make sure the charger is turned off.
X Observe the storage conditions in section
“Operating, transport and storage conditions”.
X Clean the Click Sleeves when
you take it out of the ear with
a soft and dry tissue.
X This prevents that
ear wax becomes
dry and hard.

67
X Squeeze the tip of the Click Sleeve
to remove ear wax.

Exchange standard Click Sleeve approximately every three

months. Replace them sooner if you notice cracks or other
changes.

Contact customer service if wax has collected underneath the Click

Sleeve and it cannot be wiped off.

68
Cleaning of the charger
NOTICE
Risk of injuries caused by electric shock!
X If cleaning is required, disconnect the charger
from the power supply.

X Clean the charger with a soft, dry tissue.

X Never use running water or immerse the charger in water.
X Do not sterilize or disinfect the charger.

69
Troubleshooting for hearing aids and
charger
If the status LEDs do not light up when you insert the hearing aids,
check the following:
X The hearing aids are not correctly placed. Push them slightly
into their charging cups or close the charger’s lid.
X The charger is turned off. Press and hold the button for 5
seconds to turn on the charger or connect the charger to an
electrical outlet.
X The charger’s internal battery is too low for mobile charging
Connect the charger to an electrical outlet.

70
LED Hearing aid LED
Blinking red
An error in the hearing aid has occurred.
● Take the respective hearing aid out of the charger
and disconnect the charger from the power supply.
● Contact your customer service for support.
LED is off
No hearing aid is in the charger, hearing aid is not
placed correctly, or charger is off.
Blinking twice orange
Cooling phase. Charging is resumed when the device
has cooled down.

71
 LED Charger LED
LED is off (wireless charging).
Charger is fully charged
Blinking twice orange
● Charger has reached the temperature limit and is
now in a cooling phase. Charging is resumed after
cooling down (about 15 minutes).
● Do not touch the hearing aids while the LEDs are
blinking twice orange. The hearing aids may be hot.
● In case the charger enters cooling phase multiple
times during charging, make sure to place the
charger in an environment that complies with the
recommended operating conditions.

72
 LED Charger LED
Blinking red
An error in the charger has occurred.
● Take the hearing aids out of the charger and
disconnect the charger from the power supply.
● Reconnect the charger to the power supply and
re-insert the hearing aids in the charging cups.
If the LEDs are still blinking red.
● Take the hearing aids out of the charger and
disconnect the charger from the power supply.
● Contact your customer service for support.
For an overview of the hearing aids’ charging status, refer to the
section “Charging”.

73
No LED lights are on.
● Check if the power supply is connected correctly.

For more information on troubleshooting, visit

sony.net/hearing-e10-support.

74
Technical information
Output 2cc coupler
OSPL 90 (Peak) 110 dB SPL
Full-on gain (Peak) 40 dB
Frequency range and noise
Frequency range 125 – 8000 Hz
Equivalent input noise 25 dBA
Total harmonic distortion 3% / 1%
500 Hz, 70 dB SPL /
100 dB SPL output
Latency 12 ms

75
Battery
Battery runtime (without up to 26 h
streaming)
Battery runtime (incl. 2 h up to 23 h
streaming)
Battery capacity in the charger 450 mAh
(1732 mWh)
All measurements performed according to ANSI/CTA 2051:2017.

76
 Pre-configured sound profiles
 Preconfigured
Insertion gain 

G%
 sound profiles
 profile 1

profile 2
profile 3

profile 4

profile 5

profile 6

       N+]  

f

77
Clinical data
Representative users with mild to moderate hearing impairment
experienced similar benefits when comparing the self-fitting device
with a comparable professionally fitted prescription hearing aid.
There were no adverse events encountered during this study.

Human factors data

It was demonstrated in a human factors validation study, that the
product can be used safely and effectively by the intended users
and in the intended environments. No risk of unacceptable harm
was found that could be reduced by modifying the user interface
design.

78
Damaged devices, unauthorized changes
WARNING
Risk of injury!
X Do not use damaged devices. Please consult the customer
service.

79
 WARNING
Note that any unauthorized changes to the device may cause
damage to the product or cause injury.
X Use only approved parts and accessories. Contact the
customer service for support.
X Do not modify this equipment without authorization from
the manufacturer.
X If this equipment is modified, appropriate inspection and
testing must be conducted to ensure safe use of the
equipment.

80
Restricted areas for wireless devices
WARNING
Switch off the hearing aid in areas where the use of wireless
devices is restricted.

81
Interference by strong radiation
NOTICE
Different types of strong radiation, e. g. during X-ray or MRI
head examinations, may damage hearing aids.
X Do not wear the hearing aids during these or similar
procedures like electrosurgery (diathermy, electrocautery,
HF-surgery).
Weaker radiation, e. g. from radio equipment or airport
security, does not damage the hearing aids.

82
NOTICE
Your devices comply with international standards.
However, it cannot be guaranteed that all products on the
market work interference‑free, for example some induction
cookers, electromagnetic security systems (e.g. anti-theft
systems and metal detectors) cellular telephones, RFID,
room surveillance systems may cause audible interference. If
you encounter unwanted noise in the vicinity of such device,
you should increase the distance between the hearing aid
and that device.

83
Explanation of symbols
Symbols used in this document
Points out a situation that could lead to serious,
moderate, or minor injuries.
Indicates possible property damage.

Advice and tips on how to handle your device better.

84
Symbols on the device or packaging
Do not dispose of the device with general domestic
waste. Read more in section “Disposal information”.

Read and follow the instructions in the user guide.

According to IEC 60601-1, the applied parts of this device

are classified as type B.

Keep dry during transportation and storage.

85
Symbols on the device or packaging
Temperature during transportation and storage.
Read more in section "Operating, transport and
storage conditions".
Relative humidity during transportation and storage.
Read more in section "Operating, transport and
storage conditions".
Atmospheric pressure during transportation and storage.
Read more in section "Operating,
transport and storage conditions".
Keep out of reach of children

86
Symbols on the device or packaging
Compatible with Qi-certified wireless chargers.

Bluetooth® Low Energy technology

87
Important information
The hearing aids are designed for an expected service life of 5
years. They are expected to remain safe for use for this duration.

Operating, transport and storage conditions

The hearing aids operate in the following environmental conditions
(also valid in between uses):

Temperature 0 to 50 °C (32 to 122 °F)

Relative humidity 5 to 93 %
Atmospheric pressure 700 to 1060 hPa

Note that you have to charge the hearing aids at least every
6 months.
88
Hearing aids:

Operating conditions Discharging Charging

Temperature 0 to 50 °C 10 to 35 °C
(32 to 122 °F) (50 to 95 °F)
Relative humidity 5 to 93 % 5 to 93 %
Atmospheric pressure 700 to 1060 hPa 700 to 1060 hPa

89
Charger:

Operating conditions USB-Charging QI Charging

Temperature 10 to 35 °C 10 to 30 °C
(50 to 95 °F) (50 to 86 °F)
Relative humidity 5 to 93 % 5 to 93 %
Atmospheric pressure 700 to 1060 hPa 700 to 1060 hPa

90
During extended periods of transport and storage, please observe
the following conditions:

Storage Transport
Temperature 10 to 40 °C -20 to 60 °C
(50 to 104 °F) (-4 to 140 °F)
Relative humidity 10 to 80 % 5 to 90 %
Atmospheric pressure 700 to 1060 hPa 700 to 1060 hPa

For other parts, such as batteries, other conditions may apply.

NOTICE
Local regulations may apply for shipment of devices
containing lithium-ion batteries.

91
Disposal information
Recycle hearing aids, accessories and packaging according to
local regulations.

Conformance information
Devices with the FCC marking comply with the standards of the
FCC regarding electromagnetic interference.

Notices
Changes or modifications made to this equipment not
expressly approved by the legal manufacturer may void the
FCC authorization to operate this equipment.
This device complies with Part 15 of the FCC Rules and with
ISED’s licence-exempt RSSs.
92
Operation is subject to the following conditions:
● this device may not cause harmful interference, and
● this device must accept any interference received, including
interference that may cause undesired operation.
This equipment has been tested and found to comply with the limits
for a Class B digital device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy and, if
not installed and used in accordance with the instructions, may
cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to
radio or television reception, which can be determined by turning

93
the equipment off and on, the user is encouraged to try to correct
the interference by one or more of the following measures:
● Reorient or relocate the receiving antenna.
● Increase the separation between the equipment and receiver.
● Connect the equipment to an outlet on a circuit different from
that to which the receiver is connected.
● Consult the dealer or an experienced radio/TV technician for
help.
For body worn operation, this device has been tested and meets
the FCC RF exposure guidelines when used with the legal
manufacturer’s accessories supplied or designated for this product.
Use of other accessories may not ensure compliance with FCC RF
exposure guidelines.

94
Regulatory information
FDA identifies this generic type of device as:
Self-fitting air-conduction hearing aid.
A self-fitting air-conduction hearing aid is a wearable sound
amplifying device that is intended to compensate for impaired
hearing and incorporates technology, including software, that
allows users to program their hearing aids.
This technology integrates user input with a self-fitting strategy and
enables users to independently derive and customize their hearing
aid fitting and settings.

95
For hearing aid users
Hearing aids will not restore normal hearing and will not prevent or
improve a hearing impairment resulting from organic conditions.
In most cases infrequent use of hearing aids prohibits the wearer
from attaining the full benefit from it. The use of hearing aids is only
part of hearing rehabilitation and may need to be supplemented by
auditory training and instruction in lip reading.

96
Health considerations
If soreness or skin irritation develops, discontinue wearing your
hearing aids.
Battery tips
If a battery is accidentally swallowed, seek medical attention
immediately, or call the National Button Battery Ingestion Hotline
collect at 1-800-498-8666.
Identification information
Your hearing aids have a serial number imprinted on them. The
location of the serial number will vary according to the style of
hearing aid you have chosen. Record the serial number in your
user guide for future reference.

97
The year of manufacture is incorporated into the serial number.
For in-the-ear devices, the year of manufacture is derived from the
first two digits.
The month of manufacture is derived from the first digit, the year of
manufacture from the second digit:

AB12345

AB12345

98
Code (first digit) Month Code (first digit) Month
A, N Jan G, U Jul
B, P Feb H, V Aug
C, Q Mar J, W Sep
D, R Apr K, X Oct
E, S May L, Y Nov
F, T Jun M, Z Dec

Code (second digit) Year Code (second digit) Year

B, C 2022 F, G 2024
D, E 2023 H, J 2025

99
Nearfield Magnetic Induction (NFMI) functionality
The following table shows the main information on NFMI
connectivity, some parameters are different from product to
product, so the worst case is indicated:

Wireless technology Nearfield Magnetic Induction (NFMI)

Modulation Phase Shift Key
Magnetic field 0.14 A/m
strength
Output power (EIRP) 53 μW
Range < 20 cm between hearing aids
Center frequency 3.27 MHz
Channel Single channel radio
Bandwidth 330 kHz (-15 dB)
100
Bluetooth Low Energy (BLE)
The following table shows the main information on BLE, some
parameters are different from product to product, so the worst case
is indicated:

Wireless Technology Radio frequency – Bluetooth Low Energy

(BLE)
Output power (EIRP) 3.9 mW
Range < 10 m between smartphone/accessory and
hearing instruments
Frequency 2,400 – 2,480 MHz
Channel 40 channels
Bandwidth 2 MHz per channel, 2 MHz spacing
Modulation Type Gaussian Frequency Shift Keying
101
EMI/EMC compliance
Wireless hearing aids comply with the following EMC/EMI
standards:

Standard Test Type Note

47 CFR RF emissions U.S. FCC requirements for
Part 15, intentional radiators.
Subpart C
EN 300 330 RF emissions EMC and radio spectrum
including spurious matters for short range
emission devices in the frequency
range 9 kHz ‑ 25 MHz.

102
Standard Test Type Note
EN 301 489- Immunity, Standard for low power
1/3/17 RF and ESD transmitters in the frequency
range 9 kHz ‑ 40 GHz.
IEC 60118-13 RF immunity International product
standard for hearing aids to
ensure adequate immunity
to radio interference from
mobile telephones.
ANSI C63.19 RF immunity American National Standard
method of measurement
of compatibility between
wireless communication
devices and hearing aids.

103
Standard Test Type Note
ANSI/AAMI RF emissions Implantable medical device
PC69 EMC immunity, American
National Standard.
ISO 14117 RF emissions Implantable medical device
EMC immunity, International
Standard.
EN 45502-2-1 RF emissions Particular requirements for
pacemakers.

104
Emissions CISPR 11, Group 1, Class B.
Immunity ESD, Conducted up to +/-8 kV,
Air discharge up to +/-15 kV
Power frequency magnetic fields:
30 A/m, 50/60 Hz
Immunity 80 MHz-2.7 GHz 10 V/m,
to RF fields 2.7 GHz-6 GHz 3 V/m
Proximity to wireless Up to 28 V/m –
communication devices See IEC 60601-1-2:2014/AMD1:2020,
Table 9
Proximity to magnetic 8 A/m@30 kHz, 65 A/m@134.2 kHz,
fields 7.5 A/m@50 kHz

105
Wireless security measures
Wireless signal security is assured through the device system
design that includes:
● A built-in pairing table which specifies valid and legitimate
pairing among units.
● A proprietary communication protocol which checks the package
numbers during each transmission.
● A Cyclic Redundancy Check (CRC) to check data validity.
● A convolutional encoder/decoder (Viterbi) to correct errors.

106
Quality of Service (QoS) for the ear-to-ear wireless
technology
Synchronization/exchange of low data rate ear-to-ear signals
Similar QoS as with remote controls in typical households. In
typical environment it can happen that electromagnetic noise
from appliances (light switch, car ignition) lead to non-valid data.
Transmission of unsuccessful command is automatically repeated
within approximately 3 seconds. Data transfer is checked via
CRC16 checksum.

107
Exchange of high data rate ear-to-ear signals (microphone signal).
Parameter for QoS is the bit error (BER) of the gross data link. This
parameter is estimated and monitored during data receive. For
BER > 3.5% the channel coding will become less effective thus the
transferred microphone signal is automatically muted and not used
until the QoS is good enough again. For the used ITU G.722 Audio
Codec CRC check is not useful.
It is reasonably foreseeable that no risk/hazard can rise caused by
invalid data.

108
Cybersecurity
Proper set-up and operation of your hearing aids requires a safe,
private and secure operating environment.
The U.S. Federal Trade Commission’s guidance for online security
https://consumer.ftc.gov/online-security
provides examples of best practices for securing your home
network and mobile device to ensure your security.

109
For children with hearing loss
In addition to seeing a physician for a medical evaluation, a
child with a hearing loss should be directed to an audiologist
for evaluation and rehabilitation since hearing loss may cause
problems in language development and the educational and
social growth of a child. An audiologist is qualified by training and
experience to assist in the evaluation and rehabilitation of a child
with a hearing loss.

110
Country/region specific information
Certification information for hearing aids with wireless functionality:
Sony CRE-E10
● DBIF1
● FCC ID: 2AXDT-DBIF1

111
Conformance information for charger
This device complies with EN60601-1-2.
This device complies with Part 18 of the FCC Rules.

Operation is subject to the following conditions:

● This device may not cause harmful interference,
● this device must accept any interference received, including
interference that may cause undesired operation, and
● the user shall keep a minimal distance of 20 cm (8 in) during the
charging process.

112
Support

For more detailed information, repair services or replacement:

● Visit our website: sony.net/hearing-support
● Phone: 877-864-7669
● Sony Electronics Inc., 115 West Century Road, Suite 250,
Paramus, NJ 07652

Supported systems:
For Apple iOS version 13 or above, Google Android 10 or above.
(Supported versions are subject to change.)

113
114
115
Manufactured for:
Sony Electronics Inc.
115 West Century Road
Suite 250
Paramus, NJ 07652 USA

Hearing aids: Charger: USB cable:

Made in Singapore Made in China Made in China

Document No. 05281-99T01-7600 EN

Order/Item No. 210 251 40
Master Rev01, 12.2022
Printed in Singapore.