Phonak Audéo Sphere™

User Guide

Phonak Audéo I-Sphere

Phonak Audéo I-Sphere Trial
This user guide is valid for:

Wireless hearing aids

Phonak Audéo I90-Sphere

Phonak Audéo I70-Sphere
Phonak Audéo I-Sphere Trial

Simple to follow instructions videos and

further support can be found online:
https://www.phonak.com/en-int/
support.html

Note that instructions for the

activity functions can be found in
the myPhonak User Guide.

2
Your hearing aid details

If no box is checked and you do not know the

model of your hearing aid or charging accessories,
please ask your hearing care professional.
The hearing aids described in this user guide
contain a built-in and non-removable rechargeable
lithium-ion battery.
Please also read safety information regarding
handling rechargeable hearing aids (chapter 24).

Hearing aid models Earpieces

c Audéo I-Sphere (I90/I70) c Dome
c Audéo I-Sphere Trial c SlimTip
c cShell

For further information on compatible accessories please

consult your hearing care professional.

The full list can be found at the following link:

https://www.phonak.com/audeo-i-professionals

3
Your hearing aids have been developed by Phonak –
a world leader in hearing solutions based in Zurich,
Switzerland.

These premium products are the result of decades of

research and expertise and are designed with your
well-being in mind. We thank you for making such a great
choice and wish you many years of listening pleasure.

Please read the user guide carefully to make sure that you
understand and get the best out of your device. Training
is not required for handling of this device. A hearing care
professional will help set up this device according to your
individual preferences during the fitting consultation.
For more information regarding features, benefits, set up,
use, maintenance or repairs of your hearing aid and
accessories, please contact your hearing care professional
or the manufacturer representative. Additional
information can be found in the datasheet of your
product.

Phonak - life is on
www.phonak.com
Contents

Your hearing aid
1. Quick guide 7
2. Parts of the hearing aid 9
3. Charging the hearing aids 10

Using the hearing aid
4. Left and right hearing aid markings 14
5. Putting on the hearing aid 15
6. Removing the hearing aid 16
7. Multi-function button 17
8. On/Off 18
9. Tap Control 19
10. Connectivity overview 20
11. myPhonak app overview 21
12. Roger™ overview 22
13. Initial pairing 23
14. Phone calls 25
15. Flight mode 30
16. Rebooting your hearing aid 33

5

Further information
17. Environmental conditions 34
18. Care and maintenance 36
19. Exchanging the earwax protection 39
20. Service and warranty 50
21. Compliance information 52
22. Information and description of symbols 60
23. Troubleshooting 66
24. Important safety information 72
25. For the US market only, complies with
the FDA regulations 91

6
1. Quick guide
Charging your hearing aids

Before using your hearing aid for the first time, it is

recommended to charge it for 3 hours.

After placing your hearing aid

in the charger, the indicator
light on the hearing aid will
show the charging state of the
battery until it is fully charged.
When fully charged, the
indicator light will be
constantly on, i.e. solid
green light.

Left & right hearing aid markings

Blue marking for Red marking for

left hearing aid. right hearing aid.

7
Multi-function button with indicator light
The button has several functions, the
primary function is as an on/off switch.
Together with your hearing care
professional, you can decide if it also allows
for volume control, program change and
other functionalities. This is indicated in your
individual instructions.
Phone calls: If paired with a Bluetooth® enabled phone,
a short press will accept and a long press will reject
an incoming call.
On/Off: Firmly press the lower part of the button for
3 seconds until the indicator light blinks.
On: indicator light is solid green
Off: indicator light is solid red
Enter flight mode: When device is off, press the lower part of
the button for 7 seconds until the solid orange light appears.
Then release the button.

Tap Control
If paired with a Bluetooth® enabled device, multiple functions
can be accessed using Tap Control, please refer to chapter 9.
This is also indicated in your individual instructions.
To use Tap Control tap the top of your ear twice.
8
2. Parts of the hearing aid
The following pictures show the hearing aid model
described in this user guide. You can identify your
personal models by:
• checking “Your hearing aid details” on page 3.
• comparing your earpieces, hearing aid with the
following models.

Possible earpieces

Dome SlimTip cShell

Audéo I-Sphere
Audéo I-Sphere Trial
Multi-function button
Tube with built-in
indicator light

Anchor (optional)
Speaker
(without earpiece attached)

9
3. Charging the hearing aids

Low power: You will hear two beeps when the

hearing aid battery is low. You will have
approximately 60 minutes before you have to
charge the hearing aids, after this time the hearing
aid automatically shuts down (this can vary,
depending on the hearing aid settings).
The hearing aid contains a built-in and non-
removable rechargeable lithium-ion battery.
Before using your hearing aid for the first time, it is
recommended to charge it for 3 hours.
The hearing aid must be dry before charging.
Please ensure to charge the hearing aid within
operating temperature range:
+5° to +40° Celsius (41° to 104° Fahrenheit)

10
3.1 Using the compatible charger

For more details about the charger please refer to your

charger user guide.

1.
Insert the hearing aid into the charging slots and the
earpieces in the large cavity. Make sure the left and right
hearing aid markings match the left (blue), right (red)
indicators next to the charging slots. The hearing aids will
automatically switch off once inserted into the charger.

11
2.
The indicator light on the hearing aid will show the
charging state of the battery until the hearing aid is fully
charged. When fully charged the indicator light will
remain on, i.e. solid green light.

The charging process will automatically stop when the

batteries are fully charged, so the hearing aids can be
safely left in the charger. It can take up to 3.5 hours to
charge the hearing aids. The charger lid can be closed
while charging.

Charging times

Indicator light Charging state Approx. charging times

0 – 10%
30 min (20%)
11 – 80% 60 min (40%)
120 min (70%)
81 – 99%
100% 3.5 h

12
3.
Remove the hearing aids from the charging slots by
simply lifting them out of the charger.

The hearing aid can be set to switch on automatically

when removed from the charger. The indicator light starts
blinking. The solid green light indicates the hearing aid is
ready for use.

For information on how to switch off your charger please

consult your charger User Guide.

Do not hold the tubes to remove the hearing aids

from the charger as this can damage the tubes.

13
4. Left and right hearing aid markings

There is a red or blue marking on the back of the hearing

aid and on the speaker. This will tell you if it is a left or
a right hearing aid.

Blue marking Red marking

for left hearing aid. for right hearing aid.

14
5. Putting on the hearing aid

1.
Place the hearing aid behind
your ear.

2.
Insert the earpiece into your
ear canal.

3.
If there is an anchor attached
to the earpiece, tuck it into
the bowl of your ear to secure
your hearing aid.

15
6. Removing the hearing aid

Pull on the bend of the tube

and remove the hearing aid
from behind the ear.

16
7. Multi-function button

The button has several

functions, the primary
function is as an on/off
switch. Together with your
hearing care professional,
you can decide if it also
allows for volume control,
program change and other
functionalities.
This is indicated in your individual “Hearing aid
instructions”. Please ask your hearing care professional
for a printout.

If the hearing aid is paired with a Bluetooth® enabled

phone, a short press on the upper or the lower part of the
button will accept an incoming call and a long press will
reject an incoming call – refer to chapter 14.

17
8. On/Off
Switch on hearing aid
The hearing aid is configured
to switch on automatically
when removed from the
charger. If this function is not
configured, firmly press and
hold the lower part of the
button for 3 seconds until the
indicator light blinks. Wait until the solid green light
indicates the hearing aid is ready.

Switch off hearing aid

Press and hold the lower part of button for 3 seconds
until the solid red light indicates the hearing aid is
switching off.

Blinking green Hearing aid is switching on

Solid red for 2 seconds Hearing aid is switching off

When you switch on the hearing aid you might hear

a start-up melody.

18
9. Tap Control
If paired with a Bluetooth® enabled device, multiple
functions can be accessed using Tap Control e.g.
accept/end phone call, pause/resume streaming,
start/stop voice assistant. This is indicated in your
individual “Hearing aid instructions”.

To use Tap Control tap

the top of your ear twice.

19
10. Connectivity overview
The illustration below shows the connectivity options
available for your hearing aid.

Bluetooth® enabled
device, e.g. cell
phone

TV Connector connected to TV*

Roger**

* The TV Connector can be connected to any audio source such as a TV, PC or hi-fi system.
** Roger wireless microphones can be connected to your hearing aids as well.

20
11. myPhonak app overview

Please find the Instruction for Use on

https://www.phonak.com/
myphonak
or scan the code

Install the myPhonak app

21
12. Roger™ overview

Experience the hearing performance of Roger™

Roger™ is designed to improve hearing in situations with

background noise or distance to the speaker. The
microphone picks up the voice of the speaker and
wirelessly transmits it directly to Roger receivers* in your
hearing aids. This enables you to fully participate in group
conversations even in very noisy environments such as
restaurants, meetings at work and school activities.

To learn more about the Roger technology

and microphones, please visit the webpage
https://www.phonak.com/roger-solutions
or scan the QR code.

* RogerDirect™ requires the installation of Roger receivers into the Phonak hearing aids by a
hearing care professional.

22
13. Initial pairing

13.1 Initial pairing to a Bluetooth® enabled device

It is only necessary to perform the pairing

procedure once with each device featuring
Bluetooth wireless technology. After the initial
pairing, your hearing aids will connect
automatically to the device. Initial pairing can take
up to 2 minutes.

1.
On your device (e.g. a phone), ensure that Bluetooth®
wireless technology is enabled and search for Bluetooth®
enabled devices in the connectivity setting menu.

2.
Switch on both hearing aids.
You now have 3 minutes
to pair your hearing aids
with your device.

23
3.
Your device shows a list of Bluetooth® enabled devices.
Select the hearing aid from the list to simultaneously pair
both hearing aids. A beep confirms successful pairing.

For more information about pairing instructions for

Bluetooth wireless technology, specific to some of
the most popular phone manufacturers, go to:
https://www.phonak.com/en-int/support
If several entries for your hearing aid are shown on
the list of Bluetooth enabled devices, select the one
without the prefix “LE_”.

13.2 Connecting to the device

After your hearing aids have been paired to your device,

they will automatically connect again when switched on.

The connection will be maintained as long as the

device remains ON and within range.
Your hearing aid can be connected to up to two
devices and paired to up to eight devices.

24
14. Phone calls

Your hearing aids connect directly with Bluetooth®

enabled phones. When paired and connected to your
phone, you will hear notifications, incoming call
notification and the caller’s voice directly in your hearing
aids. Phone calls are “hands free”, this means your voice is
picked up by the hearing aid’s microphones and
transmitted back to the phone.

Your voice

25
14.1 Making a call

Enter the phone number and press the dial button.

You will hear the dialing tone through your hearing aids.
Your voice is picked up by the hearing aid microphones
and transmitted to the phone.

26
14.2 Accepting a call

When receiving a call, an incoming-call notification will

be heard in the hearing aids (e.g. ring tone or voice
notification).
The call can be accepted by tapping the top of your ear
twice, a short press on the upper or lower part of the
multi-function button on the hearing aid (less than
2 seconds) or directly on your phone.

short press
< 2 sec

tap ear
twice

27
14.3 Ending a call

A call can be ended by a long press on the upper or lower

part of the multi-function button on the hearing aid
(more than 2 seconds) or directly on your phone. The
phone call can also be ended by tapping the top of your
ear twice.

long press
> 2 sec

tap ear
twice

28
14.4 Rejecting a call

An incoming call can be rejected by a long press on the

upper or lower part of the multi-function button on the
hearing aid (more than 2 seconds) or directly on your
phone.

long press
> 2 sec

29
15. Flight mode

Your hearing aids operate between 2.4 GHz–2.48 GHz

frequency range. When flying some operators require all
devices to be switched into flight mode. Entering flight
mode will not disable normal hearing aid functionality,
only the Bluetooth connectivity functions.

15.1 Enter flight mode

To disable the wireless function and enter flight mode

in each hearing aid:

30
 1. If the hearing aid is turned off,
proceed to Step 2.
If the hearing aid is on, turn it off
by pressing and holding the lower
part of the button for 3 seconds,
until the indicator light turns solid
red for 3 seconds, signifying that
the hearing aid is switching off.
2. Press and hold the lower part of
the button. The green indicator
light blinks when the hearing aid
starts up.

3. Keep pressing the button for

7 seconds, until the indicator light
is solid orange, then release the
button.
The solid orange light indicates the
hearing aid is in flight mode.

In flight mode, your hearing aid cannot connect directly

to your phone.

31
15.2 Exit flight mode

To enable the wireless function

and exit flight mode in each
hearing aid:
Switch the hearing aid off and
then on again - refer to chapter 8.

32
16. Rebooting your hearing aid

Use this technique if your hearing aid is in an error state.

This will not remove or delete any program or settings.

Press the lower part of the multi-function button for at

least 15 seconds. It does not matter if the hearing aid is
switched on or off before you start pressing the button.
After 15 seconds, the hearing aid will restart with the
indicator light blinking green.

33
17. Environmental conditions

The product is designed such that it functions without

problems or restrictions if used as intended, unless
otherwise noted in these user guides.

Please ensure to use, charge, transport and store the

hearing aids and the charger according to the following
conditions:

Charging and
Transport Storage
operating

+5 to +40 °C -20 to +60 °C -20 to +60 °C

Temperature (41 to 104 °F) (-4 to 140 °F) (-4 to 140 °F)

Humidity 0% to 90% 0% to 93% 0% to 93%

(non condensing)

Atmospheric 500 hPa to 500 hPa to 500 hPa to

pressure 1060 hPa 1060 hPa 1060 hPa

Prolonged storage at temperatures lower than 10 °C and

higher than 30 °C may negatively affect the battery
performance of the product.

34
If the device has been subject to storage and transport
conditions outside of the recommended use conditions,
bring the device back into recommended use conditions
before starting the device.

These hearing aids are classified as IP68. This means that

they are water and dust resistant and designed to
withstand daily life situations.

Please ensure to charge the hearing aids regularly during

long-term storage.

35
18. Care and maintenance

Expected Service Life:

The hearing aids and the compatible charger have the
expected service life of five years. The devices are expected
to remain safe for use for this duration.

Commercial service period:

Routine and diligent care of your hearing aids and charger
will contribute to the outstanding performance for the
duration of the expected service life of your devices.
Sonova AG will provide a minimum of a five year repair
service period after the respective hearing aid, charger and
essential components have been phased out of the
product portfolio.

Please use the following specifications as a guideline.

For further information regarding product safety, see
chapter 24.

36
General information
Before using hair spray or applying cosmetics, you should
remove your hearing aid from your ear, because these
products may damage it.

Your hearing aids are resistant to water, sweat and dust

under the following conditions:
• After exposure to water, sweat or dust, the hearing aid
is cleaned and dried.
• The hearing aid is used and maintained as described in
this user guide.

Always make sure that the hearing aids and

charger are dry and clean.

37
Daily
Hearing aid: Inspect the earpiece for earwax and moisture
deposit and clean the surfaces with a lint-free cloth. Never
use cleaning agents such as household detergents, soap,
etc. for cleaning your hearing aid. It is not recommended
to rinse with water. If you need to clean your hearing aid
intensively, ask your hearing care professional for advice
and information on filters or drying methods.

Weekly
Hearing aid: Clean the earpiece with a soft, damp cloth or
with a special cleaning cloth for hearing aids. For more
in-depth maintenance instructions, please see your
hearing care professional. Clean the charging contacts on
the hearing aid with a soft, damp cloth.

38
19. Exchanging the earwax protection

Your hearing aid is equipped with an earwax protection to

protect the speaker from earwax damage.

Please check the earwax protector regularly and exchange

it if it looks dirty or if the hearing aid volume or sound
quality is reduced. The earwax protection should be
replaced every four weeks on a regular receiver, and every
two weeks on the ActiveVent™ receiver. Your hearing care
professional can advise you on individual replacement
cycles.

19.1.1 Removing the earpiece from the speaker

1.
Remove the earpiece from the
speaker by holding the speaker
in one hand and the earpiece in
the other.

39
2.
Gently pull off the earpiece
to remove.

3.
Clean the speaker with a
lint-free cloth.

40
19.1.2 Exchanging the earwax protection with
CeruStop

1.
Insert the removal side of the
exchange tool into the used
earwax protector. The shaft
of the holder should touch the
rim of the earwax protector.

2.
Carefully pull and remove
the earwax protector straight
out of the speaker. Please do
not twist the earwax protector
when removing.

41
3.
To insert the new earwax
protector, gently push the
insertion side of the exchange
tool straight into the hole of the
speaker until the outer ring is
perfectly aligned.

4.
Pull the tool straight out.
The new earwax protector will
remain in place. Now attach
your earpiece to the speaker.

42
19.1.3 Attaching the earpiece to the speaker

1.
Hold the speaker in one hand
and the earpiece in the other.

2.
Slide the earpiece over the
speaker sound outlet.

3.
The speaker and the earpiece
should fit perfectly together.

43
19.2 ActiveVent™ receiver with SlimTip

19.2.1 Parts Explanation

1. Wax filter dispenser

a) rotating disk a
b
b) new filter c

c) dispensing slot for used

filters

2. Changing tool
a) screw end
for removing used filter

b) forked end a b
for inserting new filter

44
19.2.2 Removing the used wax filter (HF3 Filter)

1.
Hold the earpiece firmly and
secure the rear of the speaker
with your finger.

2.
Insert the screw end of the
HF3 changing tool into the
speaker of the hearing aid.

45
3.
Rotate the changing tool
clock-wise until some
resistance is felt.
Pull the changing tool out of
the speaker with the used wax
filter attached to the end.

4.
Insert the used wax filter into
the dispensing slot in the
middle of the wax filter
dispenser.

46
5.
Slide the changing tool to
either side of the dispensing
slot. Lift the changing tool up,
leaving the used wax filter in
dispensing slot.

19.2.3 Inserting a new wax filter

1.
After removing the used wax
filter from the speaker of the
hearing aid, brush away any
remaining debris.
Rotate the ridged disk of the
wax filter dispenser until a
new wax filter is visible in the
window of the disk.

47
2.
Now use the opposite end of
the changing tool (i.e. forked
end) to pick up a new wax
filter.

3.
Insert the forked end of the
changing tool down and pull
up

48
4.
Insert the new wax filter into the
speaker of the hearing aid.
Make sure to secure the rear of
speaker with your finger.

5.
Once the new filter is securely
placed in the speaker, lift the
changing tool away tilted in a
slight angle.
Reattach the changing tool to
the wax filter dispenser

49
20. Service and warranty

Local warranty
Please ask the hearing care professional where you
purchased your hearing aids about the terms of the
local warranty.

International warranty
Sonova AG offers a one year limited international
warranty, valid from the date of purchase. This
limited warranty covers manufacturing and material
defects in the hearing aid and charger respectively,
but not accessories such as tubes, earpieces, external
receivers. The warranty only comes into force if a
proof of purchase is shown.

The international warranty does not affect any legal

rights that you might have under applicable national
legislation governing sale of consumer goods.

50
Warranty limitation
This warranty does not cover damage from improper
handling or care, exposure to chemicals or undue stress.
Damage caused by third parties or non-authorized service
centers renders the warranty null and void. This warranty
does not include any services performed by a hearing care
professional in their office.

Serial numbers
Hearing aid left side:
Hearing aid right side:

Charger:

Date of purchase:

Authorized hearing care professional

(stamp/signature):

51
21. Compliance information

Europe:
Declaration of Conformity for the hearing aid
Hereby Sonova AG declares that this product meets the
requirements of the Medical Device Regulation
(EU) 2017/745 as well as the Radio Equipment Directive
2014/53/EU.
The full text of the EU Declaration of Conformity can
be obtained from the manufacturer or the local Phonak
representative whose address can be taken from the
list on https://www.phonak.com/en-int/certificates
(Phonak worldwide locations).

Australia/New Zealand:
Indicates a device’s compliance with applicable
Radio Spectrum Management’s (RSM) and
Australian Communications and Media Authority
(ACMA) regulatory arrangements for the legal
sale in New Zealand and Australia.
The compliance label R-NZ is for radio products
supplied in the New Zealand market under
conformity level A1.

52
The wireless models listed on page 2 are certified under:

Phonak Audéo I-Sphere (90/70)

Phonak Audéo I-Sphere Trial
USA FCC ID: KWC-IRP
Canada IC: 2262A-IRP

53
Notice 1:
This device complies with Part 15 of the FCC Rules and
with RSS-210 of Industry Canada. Operation is subject to
the following two conditions:
1) this device may not cause harmful interference, and
2) this device must accept any interference received,
including interference that may cause undesired operation.

Notice 2:
Changes or modifications made to this device not
expressly approved by Sonova AG may void the FCC
authorization to operate this device.

Notice 3:
This device has been tested and found to comply with
the limits for a Class B digital device, pursuant to Part 15
of the FCC Rules and ICES-003 of Industry Canada.
These limits are designed to provide reasonable protection
against harmful interference in a residential installation.

54
This device 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 device does cause harmful
interference to radio or television reception, which can be
determined by turning 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 device
and receiver.
• Connect the device into 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.

55
Radio information of your wireless hearing aid
Antenna type Resonant loop antenna

Operation frequency 2.4 GHz – 2.48 GHz

Modulation GFSK, Pi/4-DQPSK, 8-DPSK, GMSK

Radiated power < 2.5 mW

Bluetooth®

Range ~2 m

Bluetooth 5.3 Dual-Mode

Profiles supported HFP (Hands-free profile), A2DP

Emissions Test Compliance Electromagnetic environment guidance

The medical device uses RF energy only

RF emissions Group 2 for its internal function. Therefore, its RF
CISPR 11 emission are very low and are not likely
Class B to cause any interferences in nearby
electronic equipment

Harmonic Complies
emissions

Voltage
fluctuations / Complies
flicker emissions

56
Electromagnetic emissions

Manufacturer’s Declaration: The hearing aids are intended

for use in the electromagnetic environments listed below.
The user should assure that they are used in such
environments.

Emission Test Compliance Electromagnetic environment guidance

The hearing aids generate or use RF

RF emissions Group 1 energy only for their internal functioning.
CISPR 11 Therefore, the RF emissions are very low
and are not likely to cause any
interference to nearby electronic
equipment.

The hearing aids are suitable for use in

domestic establishment and in
establishment directly connected to a low
RF emissions Class B
voltage power supply network which
CISPR 11
supplies buildings used for domestic
purposes.

57
Electromagnetic immunity
Immunity IEC60601-1-2 Compliance Level
Test Test Level
Electrostatic +/- 8 kV contact +/- 8 kV contact
Discharge +/- 2 kV, +/- 4 kV, +/- 2 kV, +/- 4 kV,
(ESD) IEC +/- 8 kV, +/- 15 kV air +/- 8 kV, +/- 15 kV air
61000-4-2

Radiated RF 10 V/m 80 MHz – 2.7 GHz 10 V/m 80 MHz – 2.7

Electromag- 80% AM at 1 kHz GHz 80% AM at 1 kHz
netic Field
Immunity
Test IEC
61000-4-3

Proximity 9 V/m; 710, 745, 780 MHz; 9 V/m; 710, 745, 780
Magnetic Pulse modulation 18 Hz MHz; Pulse modulation
Field IEC 18 Hz
61000-4-3
9 V/m; 9 V/m;
5240, 5500, 5785 MHz; 5240, 5500, 5785 MHz;
Pulse modulation 217 Hz Pulse modulation 217 Hz

27 V/m; 385 MHz; Pulse 27 V/m; 385 MHz; Pulse

modulation 18 Hz modulation 18 Hz
28 V/m; 450 MHz FM +/- 5 28 V/m; 450 MHz FM
kHz deviation; 1 kHz sine +/- 5 kHz deviation;
1 kHz sine

58
Immunity IEC60601-1-2 Compliance Level
Test Test Level
Proximity 28 V/m; 810, 870, 930 MHz; 28 V/m; 810, 870,
Magnetic Pulse modulation 18 Hz 930 MHz; Pulse
Field IEC modulation 18 Hz
61000-4-3
28 V/m; 1720, 1845, 28 V/m; 1720, 1845,
1970, 2450 MHz; 1970, 2450 MHz;
Pulse modulation 217 Hz Pulse modulation 217 Hz

Rated power 30 A/m 30 A/m

frequency 50 Hz or 60 Hz 50 Hz or 60 Hz
magnetic
fields IEC
61000-4-8

59
22. Information and description of
symbols

With the CE symbol, Sonova AG confirms

that this product – including accessories –
meets the requirements of the Medical
Devices Regulation (EU) 2017/745 as well as
the Radio Equipment Directive 2014/53/EU.
The numbers after the CE symbol correspond
to the code of certified institutions that were
consulted under the above-mentioned
regulation and directive.

This symbol indicates that the products

described in these user instructions adhere to
the requirements for an applied part of Type
B of EN 60601-1. The surface of the hearing
aid is specified as an applied part of Type B.

Indicates the medical device manufacturer, as

defined in Medical Device Regulation (EU)
2017/745.

60
Indicates the date when the medical device
was manufactured

Indicates the Authorized representative in

the European Community. The EC REP is also
the importer to the European Union.

This symbol indicates that it is important for

the user to read and take into account the
relevant information in these user guides.

This symbol indicates that it is important for

the user to pay attention to the relevant
warning notices in these user guides.

This symbol indicates that it is important for

the user to pay attention to the relevant
warning notices related to batteries in these
user guides

61
 Important information for handling and
product safety.

Indicates a device’s compliance with

applicable Radio Spectrum Management’s
(RSM) and Australian Communications and
Media Authority (ACMA) regulatory
arrangements for the legal sale in New
Zealand and Australia

The Bluetooth® word mark and logos are

registered trademarks owned by Bluetooth
SIG, Inc. and any use of such marks by
Sonova AG is under license. Other trademarks
and trade names are those of their respective
owners.

Japanese mark for certified radio

equipment.

62
Indicates the manufacturer’s serial number
so that a specific medical device can be
identified.

Indicates the manufacturer’s catalogue

number so that the medical device can be
identified.

Indicates that the device is a medical device.

This symbol indicates that it is important for

the user to read and take into account the
relevant information in this user guide.

Ingress Protection Rating. IP68 rating

indicates that the hearing aid is water and
dust resistant. It survived continuous
immersion in 1 meter of fresh water for
60 minutes and 8 hours in a dust chamber as
per the IEC 60529 standard.

63
 Indicates the temperature limits to which the
medical device can be safely exposed.

Indicates the range of humidity to which the

medical device can be safely exposed.

Indicates the range of atmospheric pressure

to which the medical device can be safely
exposed.

During transportation keep dry.

This symbol indicates a device that is not safe

to use in magnetic resonance (MR)
environment (e.g. during an MRI scan).

This symbol indicates that this is a

Prescription Device. CAUTION: U.S. Federal
law restricts this device to sale by or on the
order of a physician or hearing care
professional (for US only).

64
 The symbol with the crossed-out garbage bin
is to make you aware that this hearing aid as
well as the charger may not be thrown away
as normal household waste. Please dispose of
old or unused hearing aids and charger,
at waste disposal sites intended for electronic
waste, or give your hearing aid and charger
to your hearing care professional for
disposal. Proper disposal protects the
environment and health

Symbols applicable to the European power supply only

Power supply with double isolation.

Device designed for indoor use only.

Safety isolating transformer, short circuit proof.

65
23. Troubleshooting

Cause What to do
Problem: Hearing aid not functioning
Speaker/earpiece blocked Clean speaker opening/earpiece
Hearing aid switched off Press lower part of multi-function
button for 3 seconds (chapter 7)
Battery fully discharged Charge hearing aid (chapter 3)
Hearing aid in error state Reboot the hearing aid
(chapter 16)

Problem: Hearing aid whistles

Hearing aid not inserted Insert hearing aid correctly
correctly into ear (chapter 6)
Cerumen in ear canal Contact your ENT/GP or hearing
care professional

Problem: Hearing aid too loud

Volume too loud Decrease volume if volume control
available (chapter 7)

Please check https://www.phonak.com/en-int/support.html for further

information

66
Cause What to do
Problem: Hearing aid not loud enough or distorted
Volume too low Increase volume if volume control
available (chapter 7)
Low battery Charge hearing aid (chapter 3)
Speaker/earpiece blocked Clean speaker opening/earpiece
Hearing has changed Contact your hearing care
professional

Problem: Hearing aid plays two beeps

Indication for low battery Charge hearing aid (chapter 3)

Problem: Hearing aid will not switch on

Battery fully discharged Charge hearing aid (chapter 3)

67
 Cause What to do
Problem: Indicator light on hearing aid does not light up when
hearing aid placed in charging slots
Hearing aid not inserted Insert hearing aid correctly into
correctly into charger charger (chapter 3)
Hearing aid battery fully Wait three hours after placing
discharged hearing aid in charger, regardless
of LED behavior

Problem: Indicator light on hearing aid is solid red while hearing

aid is in the charger
Hearing aid is out of its Warm hearing aid up or cool it
operating temperature range down. Operating temperature
range is +5° to +40° Celsius (+41°
to +104° Fahrenheit)
Faulty battery Contact your hearing care
professional

Please check https://www.phonak.com/en-int/support.html for further

information

68
Cause What to do
Problem: Indicator light on hearing aid switches off when hearing
aid is removed from charger
“Auto On” feature is disabled Switch on the hearing aid
(chapter 7)

Problem: Indicator light on hearing aid remains solid green after

removal from charger
Indicator light on hearing aid Reboot the hearing aid
was red when hearing aid (chapter 16)
was placed into the charger

Problem: Battery does not last the whole day

Shortened battery life Contact your hearing care
professional. A battery replacement
may be required.

Problem: Phone call function does not work

Hearing aid is in flight mode Switch hearing aid off and then on
again (chapter 15.2)
Hearing aid not paired to the Pair hearing aid to the phone
phone (chapter 14)

69
 Cause What to do
Problem: Charging does not start (but indicator light around the
charger USB port lights up green when the charger is connected to
the power outlet.)
Hearing aid not inserted Insert hearing aid correctly into
correctly into charger charger (chapter 3.1)

Problem: Hearing aid with ActiveVent™ receiver is not working

properly
Vent in wrong posiiton (e.g. Reboot by switching hearing aid
closed) off and on again
Wax, Other Clean the speaker opening and / or
change the wax filter
(chapter 19.2).
Contact your hearing care
professional.

Please check https://www.phonak.com/en-int/support.html for further

information

70
Cause What to do
Problem: ActiveVent™ receiver feels loose in earpiece or has
separated completely from earpiece
Speaker dislodged from Push the speaker back into the
earpiece (i.e during earpiece. If the speaker is still loose
exchange of earwax contact your hearing care
protection) professional.

If the problem persists, contact your hearing care

professional for assistance.

71
24. Important safety information

Please read the relevant safety information and limitations-

of-use information on the following pages before using
your hearing aid.

Intended use
The hearing aid is intended to amplify and transmit sound
to the ear and thereby compensate for impaired hearing.

The Tinnitus software feature is intended for use by people

with tinnitus who also desire amplification. It provides
supplementary noise stimulation which can help defocus
the user`s attention from their tinnitus.

Intended patient population:

This device is intended for patients with unilateral and
bilateral, mild to profound hearing loss from 8 years of age.
The Tinnitus software feature is intended for patients with
chronic tinnitus from 18 years of age.

72
Intended user:
Hearing aids: Intended for people with hearing loss using a
hearing aid and their caregivers. A hearing care
professional is responsible for adjusting the hearing aid.

Indications:
Clinical indications for the use of hearing aids and Tinnitus
software feature are:
Presence of hearing loss
• Uni- or bilateral
• Conductive, sensorineural or mixed
• Mild to profound
Presence of a chronic tinnitus (> 3 months, after
occurrence) in addition to the presence of a hearing loss
(only applicable for devices which provide the Tinnitus
feature).

Contraindications:
Clinical contra-indications for the use of hearing aids and
Tinnitus software feature are:

73
 • Acute tinnitus (< three months after it occurs)
• Deformity of the ear (i.e. closed ear canal; absence of
the auricle)
• Neural hearing loss ( i.e. retro-cochlear pathologies
such as absent / non-viable auditory nerve)

The primary criteria for the referral of a patient for a

medical or other specialist opinion and / or treatment
are as follows:
• Visible congenital or traumatic deformity of the ear;
• History of active drainage from the ear in the previous
90 days;
• History of sudden or rapidly progressive hearing loss in
one or both ears within the previous 90 days;
• Acute or chronic dizziness;
• Audiometric air-bone gap equal to or greater than
15 dB at 500 Hz, 1000 Hz and 2000 Hz;
• Visible evidence of significant cerumen accumulation or
a foreign body in the ear canal;
• Pain or discomfort in the ear;

74
 • Abnormal appearance of the eardrum and ear canal
such as:
• Inflammation of the external auditory canal
• Perforated eardrum
• Other abnormalities which the hearing care
professional believes are of medical concern
Special care should be exercised in selecting and fitting a
hearing aid whose maximum sound pressure level exceeds
132 decibels (dB) because there may be risk of impairing the
remaining hearing of the hearing aid user. (This provision is
required only for those hearing aids with a maximum sound
pressure capability greater than 132 dB).

The hearing care professional may decide that referral is

not appropriate or in the best interests of the patient
when the following applies:
• When there is sufficient evidence that the condition has
been fully investigated by a medical specialist and any
possible treatment has been provided;

75
 • The condition has not worsened or changed
significantly since the previous investigation and / or
treatment.
• If the patient has given their informed and competent
decision not to accept advice to seek a medical opinion,
it is permissible to proceed to recommend appropriate
hearing aid systems subject to the following
considerations:
• The recommendation will not have any adverse
effects on the patients health or general well
being;
• The records confirm that all necessary
considerations about the patient´s best interests
have been made

If legally required, the patient has signed a disclaimer to

confirm that the referral advice has not been accepted and
that it is an informed decision.

Clinical benefit:
Hearing aids: Improvement of speech understanding

76
Tinnitus feature: Tinnitus software feature provides
supplementary noise stimulation which can help defocus
the user`s attention from their tinnitus.

Side effects:
Physiological side-effects of hearing aids like tinnitus,
dizziness, wax build up, too much pressure, sweating or
moisture, blisters, itching and/or rashes, plugged or fullness
and their consequences like headache and/ or ear pain, may
be resolved or reduced by your hearing care professional.

Conventional hearing aids have the potential to expose

patients to higher levels of sound exposure, which might
result in threshold shifts in the frequency range affected by
acoustic trauma.

The hearing aid is suitable for the home healthcare

environment and due to their portability it may happen that
it is used in professional healthcare facility environment like
physician offices, dental offices etc.

77
A hearing aid will not restore normal hearing and will not
prevent or improve a hearing impairment resulting from
organic conditions. Infrequent use of a hearing aid does not
permit a user to attain full benefit from it. The use of
a hearing aid is only part of hearing habilitation and may
need to be supplemented by auditory training and
instruction in lipreading.
Feedback, poor sound quality, too loud or too soft sounds,
inadequate fitting or problems when chewing or
swallowing, can be resolved or improved during the
fine-tuning process at the fitting procedure by your hearing
care professional.
Any serious incident that has occurred in relation to the
hearing aid, should be reported to the manufacturer
representative and the competent authority of the state of
residence. The serious incident is described as any incident

78
that directly or indirectly led, might have led or might lead
to any of the following:
a) the death of a patient, user or other person
b) the temporary or permanent serious deterioration of
a patient’s, user’s or other person’s state of health
c) a serious public health threat
To report an unexpected operation or event, please contact
the manufacturer or a representative.

79
24.1 Warnings

The majority of hearing aid users have a hearing loss for which
a deterioration in hearing is not to be expected with regular
use of a hearing aid in everyday situations. Only a small group
of hearing aid wearers with hearing loss, may be at risk of
deterioration in hearing after a long period of use.

The hearing aids (specially programmed for each hearing loss)

must only be used by the intended person. They should not be
used by any other person as they could damage hearing.

Special medical or dental examination including radiation

described below, may adversely affect the correct functioning
of your hearing aids. Remove and keep them outside the
examination room/area before undergoing:
• Medical or dental examination with X-ray (also CT scan)
• Medical examinations with MRI/NMRI scans, generating
magnetic fields
Hearing aids don’t need to be removed when passing security
gates (airports etc.). If X-ray is used at all, it will be in very low
doses, and will not affect the hearing aids.

80
Patients implanted with magnetic externally programmable CSF
shunt valves may have a risk of experiencing an unintended
change in their valve setting when exposed to strong magnetic
fields. The receiver (loudspeaker) of hearing aids contains static
magnets. Keep a distance of 2 inches (approx. 5 cm) or more
between the magnets and the site of the implanted shunt
valve.

Hearing programs in the directional microphone mode reduce

background noises. Please be aware that warning signals or
noises coming from behind, e. g. cars, are partially or entirely
suppressed.
The hearing aids have to be dry before charging. Otherwise the
charging reliability cannot be guaranteed.

Changes or modifications to the hearing aid that were not

explicitly approved by Sonova AG are not permitted. Such
changes may damage your ear or the hearing aid.

81
 Hearing aids and their parts should be kept out of reach of
children and anyone who might swallow, choke on or
otherwise cause injury to themselves with them. If swallowed
consult a physician or hospital immediately as the hearing aid
or its parts can be poisonous. In the event of choking
immediately administer treatment or contact emergency
services.

The usage of this device by children and individuals with

cognitive impairment should be supervised at all times to
ensure their safety.

WARNING: This device uses a lithium button/coin battery.

These batteries are hazardous and can cause severe or fatal
injuries in 2 hours or less if they are swallowed or placed
inside any part of the body, whether the battery is used or
new! Keep out of the reach of children, individuals with
cognitive impairment, or pets. If you suspect that a battery
was swallowed or placed inside any part of the body,
immediately consult your physician without any delay!

82
Protect your hearing aid from heat and sunlight (never leave
near a window or in the car). Never use a microwave or other
heating devices to dry your hearing aid (due to risk of fire or
explosion). Ask your hearing care professional about suitable
drying methods.

Do not remove receiver cables from the hearing instruments. If

removal or exchange is required it is recommended to contact
the hearing care professional.

Do not use the device in explosive areas (mines or industrial

areas with danger of explosions, oxygen-rich environments or
areas where flammable anesthetics are handled). The device is
not ATEX certified.

Hearing aids should not be fitted with domes / wax protection

systems when used by clients with perforated eardrums,
inflamed ear canals or otherwise exposed middle ear cavities.
In these cases, we recommend the use of a classic earmold. In
the unlikely case that any part of this product should remain
in the ear canal, it is strongly recommended to see a physician
for safe removal.

83
 Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that
they are operating normally.

Portable RF communications equipment (including peripherals

such as antenna cables and external antennas) should be used
no closer than 30 cm (12 inches) to any part of the hearing aid
or accessory, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment
could result.

Your device operates between 2.4 GHz and 2.48 GHz frequency
range. When flying please check if flight operator requires
devices to be switched into flight mode, see corresponding
chapter regarding flight mode in this user guide.

The following is only applicable for persons with active

implantable medical devices (i.e. pacemakers, defibrillators,
etc.)

84
• Keep the wireless device at least 15 cm (6 inches) away
from the active implant. If you experience any
interference do not use the wireless hearing aids and
contact the manufacturer of the active implant. Please,
note that the interference can also be caused by
powerlines, electrostatic discharge, airport metal
detectors etc.
• Keep magnets (e.g. battery handling tool, EasyPhone
magnet, etc.) at least 15 cm (6 inches) away from the
active implant.

Do not use your hearing aid in areas where electronic

equipment is prohibited.

Use of accessories, transducers and cables other than

those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.

Do not drop your hearing aid! Dropping onto a hard

surface can damage your hearing aid.

85
 In very rare cases, the dome can remain in your ear canal
when removing the hearing tube from the ear. In the
unlikely case that the dome does get stuck in your ear
canal, it is strongly recommended to see a physician for
safe removal.

These hearing aids are water resistant. They are designed to

withstand normal activities and occasional accidental
exposure to extreme conditions. Phonak hearing aids are
not specifically designed for extended periods of water
submersion on a continual basis, that is worn in activities
such as swimming or bathing. Always remove your hearing
aid before these activities, as the hearing aid contains
sensitive electronic parts.

Warning to the Hearing Care Professionals

Data sheet values were measured with a standardized

custom shell. Please note deviation from these values may
occur based on individualized acoustic coupling. Special
care should be taken for UP-receivers as individual
deviation may lead to MPO exceeding 132dB SPL.

86
24.2 Cautions

Titanium shells of custom hearing aids and earpieces can

contain small quantities of acrylates from adhesives. People
who are sensitive to such substances may potentially
experience an allergic skin reaction. Please stop using the
device immediately if such a reaction occurs and check with
your hearing care professional or physician.

Avoid strong physical impacts to the ear when wearing a

hearing aid with customized ear piece. The stability of a
customized ear piece is designed for normal use. A strong
physical impact to the ear (e.g. during sports) may cause the
customized ear piece to break. This may lead to perforation of
the ear canal or ear drum.

After mechanical stress or shock to the hearing aid, please

ensure that the hearing aid shell is intact before placing it in
the ear.

87
 Only use the device according to chapter 17
“Environmental conditions”, page 34. Using the device
otherwise may heat the hearing aid up to temperatures,
which in the worst-case can lead to skin burns.

Make sure that you always completely dry your hearing

aid after use. Store the hearing aid in a safe, dry and
clean place.

If you feel pain in or behind your ear, if it is inflamed or if

skin irritation and accelerated accumulations of earwax
occur, please check with your hearing care professional
or physician.

Do not place these rechargeable devices in your

checked-in luggage when traveling by plane as they
contain lithium-ion batteries. The devices should be
placed in your carry-on/hand luggage.

88
Ship the rechargeable devices according to local
regulations as the devices contain lithium-ion batteries.
For shipping, they are classified as dangerous goods. If
in doubt ask the courier responsible for shipping how to
ship the devices properly.

89
24.3 Notes

If you are not using your hearing aid for a long period of time,
store it in a box with a drying capsule or in a well ventilated
location. This allows moisture to evaporate from your hearing
aid and prevents a potential impact on its performance.

The dome should be changed every three months or when it

becomes stiff or brittle. This is to prevent the dome from
detaching from the tube spout during insertion into or
removal from the ear.

Only use compatible devices for charging your hearing aids,

otherwise the devices may be damaged.

Never wash the microphone inputs. Doing so could cause it to

lose its special acoustic features.

Note to the Hearing Care Professionals

Data sheet values were measured with a standard receiver.

Please note deviation from these values may occur based on
individualized custom shell coupling.

90
25. For the US market only, complies
with the FDA regulations
Important information: Cell phones

Some hearing aid users have reported a buzzing sound

in their hearing aids when they are using cell phones.
According to the ANSI 63.19 (American National
Standard Methods of Measurement of Compatibility
between Wireless Communications Devices and Hearing
Instruments) standard, the compatibility of a particular
hearing aid and cell phone can be predicted by adding
the rating for the hearing aid immunity to the rating for
the cell phone emissions. The sum of the hearing
aid rating (e.g. M2/T2=2) and the telephone rating
(e.g. M3/T3=3) is 5, and any combination that equals
5 will provide “normal use”; a sum of 6 or greater would
indicate “excellent performance”. The equipment
performance measurements, categories and system
classifications are based upon the best information available
but cannot guarantee that all users will be satisfied. The
immunity of this hearing aid is at least M2/T2.

91
Note: the performance of individual hearing aids may
vary with individual cell phones. Therefore, please try the
hearing aid with your cell phone or, if you are purchasing
a new phone, be sure to try it with your hearing aid prior
to purchase. For additional guidance, please ask your
hearing care professional for the booklet entitled “hearing
aid compatibility with digital wireless cell phones”.

Important information in case of battery ingestion

If a battery is swallowed, call the 24-hour National

Battery Ingestion Hotline at 800-498-8666 or consult
your physician immediately.

92
Important notice for prospective noise generator users

The Tinnitus Balance noise generator is a broadband sound

Generator which may have been enabled in your hearing aid.
It provides a means of sound enrichment that can be used
as part of a personalized tinnitus management program
to provide temporary relief from tinnitus. It should always
be used as prescribed by your audiologist. The underlying
principle of sound enrichment is to provide supplementary
noise stimulation which can help defocus your attention
from your tinnitus and avoid negative reactions.
Sound enrichment, coupled with instructional counseling,
is an established approach to managing tinnitus.

Good health practice requires that a person reporting

tinnitus have a medical evaluation by a licensed ear
physician before using a sound generator. The purpose of
such an evaluation is to ensure medically treatable
conditions that may be causing tinnitus are identified
and treated prior to using a sound generator.

93
Should you develop any side effects whilst using the noise
generator such as headaches, nausea, dizziness or heart
palpitations or experience a decrease in auditory function,
you should discontinue use and seek a medical evaluation.

According to OSHA (Occupational Safety & Health

Administration, U.S. Department of Labor) regulations, the
volume of the noise generator can be set to a level which
could lead to permanent hearing damage when used for
a prolonged period of time. Should the noise generator
be set to such a level in your hearing aid, your audiologist
will advise you of the maximum amount of time per day
you should use the noise generator. The noise generator
should never be used at uncomfortable levels.

For more information visit www.phonak.com

94
Notes

95
Your hearing care professional:

029-1356-03/V1.01/2024-08/tm © 2024 Sonova AG All rights reserved

Sonova Deutschland GmbH
Max-Eyth-Strasse 20
70736 Fellbach-Oeffingen
Germany

Manufacturer:
Sonova AG
Laubisrütistrasse 28
CH-8712 Stäfa
Switzerland
www.phonak.com