Bernafon Zerena, ZR3, ZR1, ZR5, ZR9 Instructions For Use Manual

ZERENA

Instructions for Use

ITE

In-the-Ear Hearing Aids

IIC, CIC, ITC, ITE HS, ITE FS

*

only for 2.4 GHz models

*

Model overview

This booklet is valid for the Bernafon Zerena family in
the following hearing aid models, battery sizes, and
styles:

Models

Zerena 9 – ZR9
Zerena 7 – ZR7
Zerena 5 – ZR5
Zerena 3 – ZR3
Zerena 1 – ZR1

Battery size

10
312
13

2.4 GHz

Yes
No

NFMI

Yes
No

Styles

IIC Invisible-In-the-Canal
CIC Completely-In-the-Canal
ITC In-the-Canal
ITE HS In-the-Ear Half Shell
ITE FS In-the-Ear Full Shell

Introduction to this booklet

This booklet shows you how to use and maintain
your new hearing aid. Please read the booklet
carefully including the warning sections. This will

help you to achieve the full benet of your new

hearing aid.

Your hearing care professional has adjusted the
hearing aid to meet your needs. If you have further
questions, please contact your hearing care
professional.

IMPORTANT NOTICE

The hearing aid amplication is uniquely adjusted

and optimized to your hearing capabilities during

the hearing aid tting performed by your hearing

care professional.

Intended use

The hearing aid is intended to amplify and transmit
sound to the ear and thereby compensate for
impaired hearing within mild to severe hearing loss.
This hearing aid is intended for use by adults and
children older than 36 months.

Identify your hearing aid

For your in-the-ear hearing aid, there are several
different styles available with different battery sizes.
Please see the model overview for your style and
battery size. This will make it easier for you to
navigate through this booklet.

Table of contents

Size 10 battery (CIC shown) 10

Size 312 battery (ITC shown) 11

Size 13 battery (HS shown) 12

Identify left and right hearing aid 13

MultiTool for handling batteries
and cleaning 14

Turn the hearing aid ON and OFF 15

When to replace a battery 16

Replace the battery 17

Insert the hearing aid 19

Remove your hearing aid 20

Caring for your hearing aid 21

Filter replacement 23

Replace ProWax miniFit lter 24

Replace T-Cap lter 25

Replace O-Cap lter 26

Flight mode 27

Optional features and accessories 28

Change programs 29

Change volume with push button 31

Change volume with volume wheel 32

Mute the hearing aid 33

Using hearing aids with iPhone, iPad,
and iPod touch 34

Pairing hearing aid with iPhone 35

Re-connect your hearing aids to your iPhone,
iPad, or iPod touch 38

Bernafon EasyControl-A app 39

Wireless accessories 41

Other options (optional) 42

Tinnitus SoundSupport (optional) 43

Guidelines for tinnitus sound generator users 44

Sound options and volume adjustment 45

Change volume with push button 47

Change volume with volume wheel 48

Hearing aid with Bluetooth

®

49

Limitation on use time 50

Important information for hearing care
professionals about Tinnitus SoundSupport 51

Warnings related to Tinnitus SoundSupport 53

General warnings 55

Troubleshooting guide 60

Water & dust resistance (IP68) 62

Conditions of use 64

Warranty certicate 65

International warranty 66

Technical information 67

Your individual hearing aid settings 71

10

Size 10 battery (CIC shown)

What it is and does

Components may be positioned differently
on your hearing aid.

Battery drawer

Contains the

battery and

functions as

on/off switch

Pull out string

Pull out the

hearing aid

Sound outlet

Sound out

Vent Vent

Push button
(optional)

Mute, change
volume and
program

Microphone inlet

Sound in

11

Size 312 battery (ITC shown)

What it is and does

Battery drawer

Contains the

battery and

functions as

on/off switch

Sound outlet

Sound out

Vent

Push button

(optional)

Mute, change

volume and

program

Vent

Microphone inlet

Sound in

Volume
wheel

(optional)
Change
volume

12

Size 13 battery (ITE HS shown)

What it is and does

Components may be positioned differently on your
hearing aid.

Battery drawer

Contains the battery
and functions as
on/off switch

Microphone

inlet

Sound in

Vent

Push button (optional)

Mute, change volume

and program

Volume wheel (optional)
Change volume

Sound outlet

Sound out

Vent

Wax lter

Wax protection of speaker

13

Identify left and right hearing aid

It is important to distinguish between the left and the
right hearing aid as they might be shaped and
programmed differently.

A BLUE shell,
dot or text identies
the LEFT hearing aid*

A RED shell,
dot or text identies
the RIGHT hearing aid*

* Shell and dot is only available for IIC

14

IMPORTANT NOTICE

The MultiTool has a built-in magnet. Keep the
MultiTool at least 30 cm away from credit cards
and other magnetically sensitive devices.

Brush

Wire loop

Magnet

MultiTool for handling batteries
and cleaning

The MultiTool contains a magnet that makes it easier
to replace the battery in the hearing aid. It also
contains a brush and a wire loop for cleaning and
removing ear wax from your earpiece. If you need a
new MultiTool, please contact your hearing care
professional.

15

Turn the hearing aid ON and OFF

The battery drawer is also used to switch the hearing
aid on and off. To preserve the battery, make sure
your hearing aid is switched off when you are not
wearing it. If you wish to return to the standard
settings of the hearing aid programmed by your
hearing care professional, simply open and then
close the battery drawer.

Turn ON

Close the battery drawer
with the battery in place

Turn OFF

Open the battery drawer

 ✻

Whenever the hearing instrument is not in use for
longer periods of time (e.g., at night), fully open the
battery door to allow air to circulate and to make sure
the hearing aid does not drain the battery.

16

 ✻

Batteries need to be replaced more often if you are
streaming audio or music to your hearing aids.

When to replace a battery

When it is time to replace the battery, you will hear
three beeps repeated at moderate intervals until the
battery runs out.

Battery tip

To make sure the hearing aid is always working, bring
spare batteries with you, or replace the battery
before you leave home.

*If your hearing aid has Bluetooth® this will be turned off

and it will not be possible to use wireless accessories.

The Bluetooth

®

word mark and logos are registered
trademarks owned by the Bluetooth SIG, Inc. and any use
of such marks by William Demant Holding A/S is under
license. Other trademarks and trade names are those of
their respective owners.

Three beeps*

The battery is running low

Four beeps

The battery has run out

17

1. Remove

Fully open the battery
drawer. Remove the battery.

2. Uncover

Remove the sticky label from
the + side of the new battery.

Tip:
Wait 2 minutes so that the
battery can draw air, to
ensure optimal functioning.

3. Insert

Insert the new battery into
the battery drawer.
Make sure the + side faces
the + on the battery drawer.

Replace the battery

18

4. Close

Close the battery drawer.
The hearing aid will play a
jingle through the earpiece.
Hold the earpiece close to
your ear to hear the jingle.

Tip

The MultiTool can be used for battery change.
Use the magnetic end to remove and insert batteries.

The MultiTool is provided by your hearing care
professional.

MultiTool

19

Insert the hearing aid

Step 1

Place the tip of the hearing aid in
your ear canal.

Step 2

Gently pull your ear outwards and
push the hearing aid into the ear
canal, twisting slightly if
necessary. Follow the natural
contour of the ear canal. Push the

hearing aid to make sure it ts

comfortably in the ear.

20

Remove your hearing aid

Hold the hearing aid by the pull-out string (if
available). Gently pull the hearing aid from the ear
canal.

If your hearing aid doesn’t have a pull-out string, you
can remove it by pulling on the edge of the hearing
aid.

IMPORTANT NOTICE

DO NOT use the battery door as a handle to insert
or remove your hearing aid. It is not designed for
this purpose.

21

Caring for your hearing aid

When handling your hearing aid, hold it over a soft
surface to avoid damage if you drop it.

Cleaning the hearing aid

Carefully brush away debris from the microphone
inlets with a clean brush. Gently brush the surface.

Make sure that the lters do not fall off.

Microphone

inlets

22

IMPORTANT NOTICE

Use a soft, dry cloth to clean the hearing aid.
It must never be washed or immersed in water
or other liquids.

Clean the vent by pressing the brush through the
hole while twisting it slightly.

Vent

Vent

If the vent is very small, a special
tool may be required. Please consult
your hearing care professional.

23

IMPORTANT NOTICE

Always use the same type of wax lter as was

originally supplied with the hearing aid. If you are in
any doubt about the use or replacement of wax

lters, contact your hearing care professional.

Filter replacement

The lters keep wax and debris from damaging the
hearing aid. If the lters become clogged, please
replace the lters or contact your hearing care

professional.

· ProWax miniFit lter protects the sound outlet.

· O-Cap and T-Cap protect the microphone inlet.

Please refer to the following pages for instructions

on how to replace the appropriate lters.

24

Replace ProWax miniFit filter

1. Tool

Remove the tool from the
shell. The tool has two pins,
one empty for removal and
one with the new ProWax

miniFit lter.

2. Remove

Push the empty pin into the

ProWax miniFit lter in the

hearing aid and pull it out.

New lter

3. Insert

Insert the new ProWax miniFit

lter using the other pin,

remove the tool and throw it
out.

New lter

25

Replace T-Cap filter

(hearing aids with size 10 batteries)

1. Tool

Remove the tool from the
packaging. The tool has two
ends, one for removal and one

with the new T-Cap lter.

New lter

2. Remove

Push the tool fork under the
top edge of the used T-Cap

lter and lift it out.

3. Insert

Insert the new T-Cap lter and

remove the tool by twisting it
slightly. Discard the tool after
use.

26

Replace O-Cap filter

(hearing aids with size 312 and size 13 batteries)

1. Tool

Remove the tool from the
packaging. The tool has two
ends, one for removal and one

with the new O-Cap lter.

New lter

2. Remove

Push the pointed end of the
tool into the existing O-Cap

lter and pull it out.

3. Insert

Insert the new O-Cap lter

using the other end of the
tool. Discard the tool after
use.

27

Flight mode

(hearing aids with Bluetooth

®

and push button)

When boarding an airplane or entering an area in which
it is prohibited to radiate radio signals, for example

during ight, ight mode must be activated. The

hearing aid will still be working. It is only necessary to

activate ight mode on one hearing aid, to turn off

Bluetooth

®

on both hearing aids. If your hearing aid
does not have a push button, you need to turn off your
hearing aid.

To activate and deactivate

Press the push button for at

least 7 seconds. A jingle

conrms your action.

Opening and closing the

battery drawer for each

hearing aid will also

deactivate the ight mode.

28

Optional features and accessories

The features and accessories described on the
following pages are optional. Please contact your

hearing care professional to nd out how your
hearing aid is programmed. If you experience difcult

listening situations, a special program may be
helpful. These are programmed by your hearing care
professional.

Write down any hearing situations in which you may
need help.

29

Change programs

Your hearing aid can have up to 4 different programs.
These are programmed by your hearing care
professional.

Press the button to change
program. Use a short press if the
push button is used for program
change only and a long press if it is
also used for volume control.

Note that if you have two
synchronized hearing aids (both
hearing aids respond when either
push button is operated), the RIGHT
hearing aid switches forward from
for example, program 1 to 2 and the
LEFT hearing aid switches
backwards from for example,
program 4 to 3.

If your hearing aids work
independently, you must press the
buttons on each hearing aid.

30

To be lled out by the hearing care professional

Program Sound you will hear

when activated

When to use

1

“1 beep”

2

“2 beeps”

3

“3 beeps”

4

“4 be e ps”

Program change:

Independent Synchronized*

LEFT RIGHT

Short press Long press

* Only available for models with NFMI

31

Change volume with push button

The push button allows you to adjust the volume.
You may hear a click when you turn the volume up or
down.

A short press on the RIGHT
hearing aid increases the volume

A short press on the LEFT
hearing aid decreases the volume

You will hear 2 beeps at
the start-up level.
You will hear 3 beeps at
Maximum and Minimum.

Maximum

Minimum

Start-up level

To be lled out by the hearing care professional

Volume change

LEFT RIGHT

32

Change volume with volume wheel

The volume wheel allows you to adjust the volume.
You may hear a click when you turn the volume up or
down.

Turn forward to
turn up volume

Turn backwards to turn
down the volume

Down Up

33

Mute the hearing aid

Use the mute function if you need to silence the
hearing aid. Only available for hearing aids with push
button.

IMPORTANT NOTICE

Do not use the mute function as an off switch, as
the hearing aid still draws current from the battery
in this mode.

Apply a very long press
(4 seconds) to the push button
to mute the hearing aid.

To reactivate the hearing aid,

push the button briey.

34

Using hearing aids with iPhone, iPad,
and iPod touch

Your hearing aids are Made for iPhone® and allow for
direct communication and control with an iPhone

®

,

iPad

®

or iPod® touch.

For assistance in pairing and using these products
with your hearing aid, please contact your hearing
care professional or visit our support site at:
www.bernafon.com/library.

Zerena is compatible with iPhone X, iPhone 8 Plus,
iPhone 8, iPhone 7 Plus, iPhone 7, iPhone SE, iPhone 6s
Plus, iPhone 6s, iPhone 6 Plus, iPhone 6, iPhone 5s,
iPhone 5c, iPhone 5, 9.7-inch iPad Pro, 12.9-inch
iPad Pro, iPad Air 2, iPad Air, iPad (4th generation),
iPad mini 4, iPad mini 3, iPad mini 2, iPad mini, and
iPod touch (5th and 6th generation). Devices must be
running iOS 9.3 or later.

“Made for iPod”, “Made for iPhone”, and “Made for
iPad” mean that an electronic accessory has been

designed to connect specically to iPod, iPhone, or iPad,
respectively, and has been certied 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 iPod, iPhone, or
iPad may affect wireless performance.

35

Pairing hearing aid with iPhone

2. General1. Settings

On the “General”
screen, choose
"Accessibility".

Open your iPhone and
go to “Settings”.
Make sure Bluetooth

®

is on. Then choose
“General”.

General

Accessibility

Bluetooth On

36

4. Prepare3. Accessibility

Open and close the
battery drawer on both
hearing aids, and place
them close to your
iPhone. The hearing aids
remain in pairing mode
for 3 minutes.

On the “Accessibility”
screen, choose
“MFi Hearing Devices”.

MFi Hearing Devices

37

6. Conrm pairing5. Select

Conrm pairing. If you

have two hearing aids,

pairing conrmation is

needed for each
hearing aid.

Your iPhone will detect
the hearing aids for
pairing. Detected
devices will appear in
your iPhone list.
Choose your hearing
aids.

Andrea’s Hearing Devices

Bernafon Zerena 9

Bluethooth Pairing Request

"Andrea's Hearing Devices" would

like to pair with your iPhone

Cancel Pair

38

Re-connect your hearing aids to your
iPhone, iPad, or iPod touch

When you turn off your hearing aids or Apple device,
these will no longer be connected. To connect them
again, turn on your hearing aids by opening and
closing the battery door. The hearing aids will then
automatically re-connect to your Apple device.

39

Bernafon EasyControl-A app

Bernafon EasyControl-A app for iPhone, iPad, iPod
touch, and Android™ devices offers an intuitive and
discreet way to control your hearing aid. Bernafon
EasyControl-A app also enables you to connect and
control an endless range of other devices by linking
to IFTTT via the internet.

Go to www.bernafon.com/products/accessories for
more details and information on compatibility.
Bernafon EasyControl-A app is available on App
Store

®

and on Google Play™. When downloading
Bernafon EasyControl-A app on iPad, search for
iPhone apps on App Store.

 ✻

Direct audio streaming is currently not supported by
Android.

40

Please nd more details here:
www.bernafon.com/products/accessories.

Apple, the Apple logo, iPhone, iPad, iPod touch, and
Apple Watch are trademarks of Apple Inc., registered in
the U.S. and other countries.
App Store is a service mark of Apple Inc. Android, Google
Play, and the Google Play logo are trademarks of
Google LLC.

41

Wireless accessories (optional)

As an enhancement to your wireless hearing aid, a
range of wireless accessories are available. They can
enable you to hear and communicate better in a lot of
everyday situations.

SoundClip-A

When this device is paired with your mobile phone,
you can use the hearing aids like stereo headphones.
SoundClip-A can also function as a remote
microphone and remote control.

TV-A

TV-A adapter is a wireless transmitter of sound from
TV and electronic audio devices. The TV-A streams
sound directly to your hearing aid.

RC-A

RC-A remote control offers the ability to change
programs, adjust volume or mute your hearing aid.

Bernafon EasyControl-A app

Offers an intuitive and discreet way to control your
hearing aids. For iPhone, iPad, iPod touch, and
Android devices.

For more information, please contact your hearing
care professional or visit:
www.bernafon.com/products/accessories.

42

Other options

Telecoil – only optional for some styles*

Telecoil helps you hear better when
using a telephone with a built-in loop or
when you are in buildings with teleloop
systems such as theaters, churches, or
lecture rooms. This symbol or a similar
sign is shown wherever a teleloop has
been installed.

Auto Telephone – only optional for some styles

The Auto Telephone can automatically
activate a phone program in the hearing
aid, if your telephone has a dedicated
magnet. The magnet needs to be
placed on your telephone next to the
sound outlet.

* Be aware that when you activate 2.4 GHz and Telecoil at

the same time, an artifact sound can occur

For more information, please contact your hearing
care professional.

43

Tinnitus SoundSupport (optional)

Intended use of Tinnitus SoundSupport

Tinnitus SoundSupport is a tool intended to generate
sounds to provide temporary relief for patients
suffering from tinnitus as part of a tinnitus
management program.

The target population is the adult population
(over 18 years old).

Tinnitus SoundSupport is targeted to licensed
hearing care professionals (audiologists, hearing aid
specialists, or otolaryngologists) who are familiar
with the evaluation and treatment of tinnitus and
hearing loss. Fitting of Tinnitus SoundSupport must
be done by a hearing care professional participating
in a tinnitus management program.

Styles available with Tinnitus SoundSupport

CIC, ITC, ITE HS & ITE FS for hearing aids with push

button. Please see the model overview to nd out

which style your hearing aid is.

44

Guidelines for tinnitus sound
generator users

These instructions contain information about Tinnitus
SoundSupport, which may have been enabled in your
hearing aids by your hearing care professional.

Tinnitus SoundSupport is a tinnitus management

device intended to generate sound of sufcient

intensity and bandwidth to help manage tinnitus.

Your hearing care professional will also be able to
offer the appropriate follow-up care. It is important to
follow his/her advice and directions regarding such
care.

Prescription use only

Good health practice requires that a person reporting
tinnitus has had a medical evaluation by a licensed
ear physician before using a sound generator. The
purpose of such an evaluation is to ensure that any
medically treatable condition that may cause tinnitus

is identied and treated prior to using a sound

generator.

45

Sound options and volume adjustment

Tinnitus SoundSupport is programmed by your
hearing care professional to match your hearing loss
and preferences for tinnitus relief. It offers a number
of different sound options. Together with your
hearing care professional, you can select your
preferred sound(s).

Tinnitus SoundSupport programs

Together with your hearing care professional, you
decide for which programs you may want to have
Tinnitus SoundSupport activated. The sound
generator can be activated in up to four different
programs.

46

Mute

If you are in a program for which Tinnitus
SoundSupport is activated, the mute functionality
will mute only the environmental sounds, and not the
sound from Tinnitus SoundSupport. See chapter:
“Mute the hearing aid”.

Volume adjustments with Tinnitus
SoundSupport

When you select a hearing aid program for which
Tinnitus SoundSupport is activated, your hearing care
professional can only set the push button on your
hearing aid to work as a volume control for the
tinnitus relief sound.

Your hearing care professional will set the volume
control for the sound generator in one of two ways:

A) change volume in each ear separately, or
B) change volume in both ears simultaneously.

47

A) How to change Tinnitus SoundSupport
volume in each ear separately

To increase volume (on one hearing aid only), use
a short press on the push button repeatedly until
desired level is reached. The sound will always be

louder with the rst press(es) until two beeps are

heard. Hereafter, the volume will decrease.
To decrease volume (on only one hearing aid),
continue to press the push button repeatedly until
desired level is reached.

B) How to change Tinnitus SoundSupport
volume in both ears simultaneously

You can use one hearing aid to increase the
sound and the other hearing aid to decrease the
sound.
To increase volume, use a short press on the
push button repeatedly on the RIGHT hearing aid.
To decrease volume, use a short press on the
push button repeatedly on the LEFT hearing aid.

To be lled out by your hearing care professional.

Change volume with push button

See section “Change volume with push button”
for illustration.

48

A) How to change Tinnitus SoundSupport
volume in each ear separately

To increase volume (on one hearing aid only),
turn the volume wheel forward.
To decrease volume (on one hearing aid only),
turn the volume wheel backwards.

B) How to change Tinnitus SoundSupport
volume in both ears simultaneously

You can use one hearing aid to increase/decrease
the sound in both hearing aids. When changing
the volume in one hearing aid, the volume on the
other hearing aid will follow.
To increase volume, turn the volume wheel
forward.
To decrease volume, turn the volume wheel
backwards.

To be lled out by your hearing care professional.

Change volume with volume wheel

See section “Change volume with volume wheel”
for illustration.

49

Hearing aid with Bluetooth

®

If your hearing aid has Bluetooth® connection, you
will be able to adjust the environmental sounds in a
program with Tinnitus SoundSupport with
EasyControl-A or SoundClip-A.

EasyControl-A app for iPhone, iPad, iPod touch, and
Android™ devices offers the possibility to adjust
both the environmental sound and the Tinnitus
SoundSupport in each program directly from the app.

50

Limitation on use time

Daily use

The volume levels of Tinnitus SoundSupport can be
set to a level which could lead to permanent hearing
damage when used for a prolonged period of time.
Your hearing care professional will advise you of the
maximum amount of time per day you should use
Tinnitus SoundSupport. It should never be used at
uncomfortable levels.

See table “Tinnitus SoundSupport: Limitation on
use” at the end of this booklet to learn how many
hours per day you can safely use the relief sound in
your hearing aids.

51

Important information for hearing care
professionals about Tinnitus SoundSupport

Device description

Tinnitus SoundSupport is a module function that can
be enabled in the hearing aids by the hearing care
professional.

Maximum wearing time

The wearing time of Tinnitus SoundSupport will
decrease as you increase the level above

80 dB(A) SPL. The tting software will automatically

display a warning when the hearing aid exceeds
80 dB(A) SPL. See “max wearing time indicator” next

to the tinnitus tting graph in the tting software.

The volume control is deactivated

By default, the volume control for the sound
generator is deactivated in the hearing aid. Risk of
noise exposure increases when the volume control is
activated.

52

If the volume control is activated

A warning may be displayed if you activate the
tinnitus volume control in the “Buttons & Indicators”
screen. This occurs if the relief sound can be listened
to at levels that may cause hearing damage. The

“Limitation on Use” table in the tting software

displays the number of hours the patient can safely
use Tinnitus SoundSupport.

· Note the max wearing time for each program for

which Tinnitus SoundSupport is activated.

· Write those values in the table:

“Tinnitus SoundSupport: Limitation on use”,
in the back of this booklet.

· Instruct your patient accordingly.

The Tinnitus SoundSupport is manufactured for
Bernafon AG.

53

Warnings related to Tinnitus

SoundSupport

If your hearing care professional has activated the
sound generator Tinnitus SoundSupport, please pay
attention to the following warnings.

There are some potential concerns associated with
the use of any sound generated by a tinnitus
management device. Among them are the potential
worsening of tinnitus, and/or a possible change in
hearing thresholds.

Should you experience or notice a change in hearing
or tinnitus, or any dizziness, nausea, headaches,
heart palpitations, or possible skin irritation at the
point of contact with the device, you should
immediately discontinue use of the device and
consult a medical, audiology, or other hearing care
professional.

As with any device, misuse of the sound generator
feature may cause potentially harmful effects. Care
should be taken to prevent unauthorized use and to
keep the device out of reach of children and pets.

54

Maximum wearing time

Always follow the maximum wearing time per day of
the Tinnitus SoundSupport advised by your hearing
care professional. Prolonged use may lead to
worsening of your tinnitus or of your hearing loss.

55

General warnings

You should familiarize yourself fully with the
following general warnings before using your hearing
aid for your personal safety and to ensure correct
use.

Please note that a hearing aid will not restore normal
hearing and will not prevent or improve a hearing
impairment resulting from organic conditions.
Furthermore, note that in most cases, infrequent use
of a hearing aid does not permit a user to attain full

benet from it.

Consult your hearing care professional if you
experience unexpected operations or events with
your hearing aid.

Usage of hearing aids

· Hearing aids should be used only as directed and

adjusted by your hearing care professional. Misuse
can result in sudden and permanent hearing loss.

· Never allow others to wear your hearing aid, as

incorrect usage could cause permanent damage to
their hearing.

56

Choking hazards & risk of swallowing batteries

and other small parts

· Hearing aids, their parts, and batteries should be

kept out of reach of children and anyone who might
swallow these items or otherwise cause injury to
themselves.

· Batteries have occasionally been mistaken for pills.

Therefore, check your medicine carefully before
swallowing any pills.

· Most hearing aids can be supplied with a

tamper-resistant battery drawer upon request. This
is strongly recommended for infants, small children,

and people with learning difculties.

· Children younger than 36 months must always use

a tamper-resistant battery drawer. Please talk to
your hearing care professional about the availability
of this option.

If a battery or hearing aid is swallowed, see a

doctor immediately.

Battery use

· Always use batteries recommended by your

hearing care professional. Batteries of low quality
may leak and cause bodily harm.

· Never attempt to recharge your batteries, and

never dispose of batteries by burning them.
There is a risk that the batteries will explode.

57

Dysfunction

· Be aware of the possibility that your hearing aid

may stop working without notice. Keep this in mind
when you depend on warning sounds (for example

when you are in trafc). The hearing aids may stop

functioning, for instance if the batteries have
expired or if the tubing is blocked by moisture or
ear wax.

Active implants

· Caution must be taken with active implants.

In general, follow the guidelines recommended by

manufacturers of implantable debrillators and

pacemakers regarding use with mobile phones and
magnets.

· The Auto Telephone magnet and MultiTool (which

has a built-in magnet) should be kept more than
30 cm away from the implant, for example, do not
carry it in a breast pocket.

· If you have an active brain implant, please contact

the manufacturer of your implantable device for
information about the risk of disturbance.

X-ray, CT, MR, PET scanning and electrotherapy

· Remove your hearing aid before X-ray, CT/MR/PET

scanning electrotherapy, surgery etc. as your
hearing aid may be damaged when exposed to

strong elds.

General warnings

58

Heat and chemicals

· The hearing aid must never be exposed to extreme

heat, for example, left inside a parked car in the sun.

· The hearing aid must not be dried in microwave

ovens or other ovens.

· The chemicals in cosmetics, hairspray, perfume,

aftershave lotion, suntan lotion and insect repellent
can damage the hearing aid. Always remove your
hearing aid before applying such products and allow
time to dry before use.

Power instrument

· Special care should be exercised in selecting, tting

and using a hearing aid where maximum sound
pressure capability exceeds 132 dB SPL (IEC 711), as
there may be risk of impairing the remaining hearing
of the hearing aid user.

For information on whether your hearing aid is a
power instrument, see the "Model overview" section
in the front of this booklet.

Possible side effects

· Hearing aids and earpieces may cause an

accelerated accumulation of ear wax.

· The otherwise non-allergenic materials used in

hearing aids may in rare cases cause a skin
irritation or other side effects.

Please seek consultation with a physician if these
conditions occur.

59

General warnings

Interference

· The hearing aid has been thoroughly tested for

interference, according to the most stringent
international standards. However, interference
between the hearing aid and other devices
(e.g. some mobile telephones, citizens band
systems and shop alarm systems and other devices)
may occur. If this occurs, increase the distance
between the hearing aid and the interfering device.

Use on aircraft

· Your hearing aid contains Bluetooth

®

. On board an

aircraft, ight mode must be activated, unless

Bluetooth

®

is permitted by the ight personnel.

Please see the model overview to see if your hearing
aid has Bluetooth

®

.

Connection to external equipment

· The safety of the hearing aid when connected

to external equipment with an auxiliary input cable
and/or with a USB cable and/or directly, is
determined by the external signal source. When
connected to external equipment plugged into a wall
outlet, this equipment must comply with IEC-62368
(or IEC-60065, IEC-60950 until June 20, 2019) or
equivalent safety standards.

60

Troubleshooting guide

Symptom Possible causes

No sound

Dead battery

Clogged sound outlet

Clogged microphone inlet

Hearing aid microphone muted

Intermittent or
reduced sound

Clogged sound outlet

Moisture

Dead battery

Squealing noise

Hearing aid not inserted
properly

Ear wax accumulated
in ear canal

Pairing issue
with Apple
device

Bluetooth

®

connection failed

Only one hearing aid paired

61

Solutions

Replace the battery

Clean sound outlet* or replace the wax lter

Clean microphone inlet* or replace lter

(T-Cap or O-Cap)

Un-mute the hearing aid microphone

Clean sound outlet or replace the wax lter

Wipe battery and hearing aid with a dry cloth

Replace the battery

Re-insert the hearing aid

Have ear canal examined by your doctor

1. Unpair your hearing aids

(Settings g General g Accessibility g Hearing
Devices g Devices g Forget this device).

2. Turn Bluetooth

®

off and on again.

3. Open and close battery drawer on hearing aids.

4. Re-pair hearing aids (see section “Pair Hearing

Aids with iPhone”).

If none of the above solutions work, consult your
hearing care professional for assistance.

* According to guideline in this booklet

62

Water & dust resistance (IP68)

Your hearing aid is dust-tight and protected against
ingress of water which means it is designed to be
worn in all daily life situations. Therefore, you do not
have to worry about sweat or getting wet in the rain.
Should your hearing aid come in contact with water
and stop working, please follow these guidelines:

1. Gently wipe off any water.

2. Open the battery drawer and remove the battery

and gently wipe off any water in the battery
drawer.

3. Let the hearing aid dry with the battery drawer left

open for approximately 30 minutes.

4. Insert a new battery.

IMPORTANT NOTICE

Do not wear your hearing aid while showering or
participating in water activities. Do not immerse
your hearing aid in water or other liquids.

63

Operating
conditions

Temperature:
+1 °C to +40 °C
Relative humidity:
5 % to 93 %, non-condensing

Storage and
transportation
conditions

Temperature and humidity should
not exceed the following
limits for extended periods during
transportation and storage:

Temperature:
– 25 °C to +60 °C
Relative humidity:
5 % to 93 %, non-condensing

Conditions of use

64

Warranty certificate

Name of owner:

Hearing care professional:

Hearing care professional address:

Hearing care professional phone:

Purchase date:

Warranty period: Month:

Model right: Serial no.:

Model left: Serial no.:

Battery size:

65

International warranty

Your hearing aid is covered by an international limited
warranty issued by the manufacturer for a period of
12 months from the date of delivery. This limited
warranty covers manufacturing and material defects
in the hearing aid itself, but not in accessories such

as batteries, tubing, speakers, earpieces and lters,

etc. Problems arising from improper/incorrect
handling or care, excessive use, accidents, repairs
made by an unauthorized party, exposure to
corrosive conditions, physical changes in your ear,
damage due to foreign objects entering the device or
incorrect adjustments are NOT covered by the
limited warranty and may void it. The above warranty
does not affect any legal rights that you might have
under applicable national legislation governing sale of
consumer goods. Your hearing care professional may
have issued a warranty that goes beyond the clauses
of this limited warranty. Please consult him/her for
further information.

If you need service

Take your hearing aid to your hearing care professional,
who may be able to sort out minor problems and
adjustments immediately.

66

Technical information

The hearing aid contains two radio technologies,
which are described below:

The hearing aid contains a radio transceiver using
short range magnetic induction technology working

at 3.84 MHz. The magnetic eld strength of the

transmitter is very weak and is always below

–40 dBμA/m at a 10 meter distance.

The hearing aid also contains a radio transceiver
using Bluetooth

®

Low Energy (BLE) and a proprietary
short range radio technology both working at ISM
band 2.4 GHz. The radio transmitter is weak and is
always below 4.8 dBm e.i.r.p. in total radiated power.

The hearing aid complies with international standards
concerning electromagnetic compatibility and human
exposure.

Due to the limited space available on the hearing aid,
relevant approval markings can be found in this
document.

Additional information can be found in the
“Product Information”

on www.bernafon.com.

67

USA and Canada

The hearing aid contains a radio module with the

following certication ID numbers:

CIC NFMI instruments contain a module with:

FCC ID: U6XAUCIC
IC: 7031A-AUCIC

ITC, ITE HS & ITE FS 2.4 GHz instruments contain a
module with:

Battery size 13:
FCC ID: U6XAUITE13
IC: 7031A-AUITE13

Battery size 312:
FCC ID: U6XAUITE312
IC: 7031A-AUITE312

The device complies with Part 15 of the FCC Rules
and with Industry Canada’s licence-exempt RSSs.

Operation is subject to the following two conditions:

1. This device may not cause harmful interference.

2. This device must accept any interference received,

including interference that may cause undesired
operation.

68

The manufacturer declares that this hearing aid is in
compliance with the essential requirements and other
relevant provisions of Directive 2014/53/EU.

Declaration of Conformity is available from the
manufacturer.

Bernafon AG

Morgenstrasse

131
CH-3018 Bern
Switzerland

Waste from electronic
equipment must be handled
according to local regulations.

69

Your individual hearing aid settings

To be lled out by your hearing care professional.

Settings overview for your hearing aid

Left Right

Yes No

Volume control

Yes No

Yes No

Program shift

Yes No

Yes No

Mute

Yes No

Yes No

Tinnitus SoundSupport

Yes No

Volume control indicators

On Off

Beeps at min/max

volume

On Off

On Off

Clicks when changing

volume

On Off

On Off

Beeps at preferred

volume

On Off

Battery indicators

On Off

Low battery warning

On Off

70

Warnings

Text marked with a marking symbol must be
read before using the product.

Manufacturer

The product is produced by the manufacturer
whose name and address are stated next to
the symbol. Indicates the medical device

manufacturer, as dened in EU Directives

90/385/EEC, 93/42/EEC and 98/79/EC.

CE mark

The product complies with Medical Device
Directive 93/42/EEC. The four digits number

indicates the identication of the notied body.

Electronic waste (WEEE)

Recycle your hearing aids, accessories or
batteries according to local regulations or
return them to your hearing care professional
for disposal.
Electronic equipment covered by Directive
2012/19/EU on waste and electrical equipment
(WEEE).

Regulatory Compliance Mark (RCM)

The product complies with electrical safety,
EMC and radio spectrum requirements for
products supplied to the Australian or New
Zealand market.

IP68

IP code

This symbol indicates the class of protections
against harmful ingress of water and particulate
matter according to EN 60529:1991/A1:2002.
IP6X indicates total dust protection.
IPX8 indicates the protection against the
effects of continuous immersion in water.

Description of symbols used in this booklet or on

the packaging label

71

Bluetooth® logo

Registered trademark of Bluetooth® SIG, Inc.
where any use of such requires a license.

Made for iPod, iPhone, and iPad

Indicates that the device is compatible with
iPod, iPhone and iPad.
Description of symbols used on the packaging
label.

Keep dry

Indicates a medical device that needs to be
protected from moisture.

Caution symbol

Consult instructions for use for warnings and
cautions.

REF

Catalogue number

Indicates the manufacturer’s catalogue number

so that the medical device can be identied.

SN

Serial number

Indicates the manufacturer’s serial number so

that a specic medical device can be identied.

72

Tinnitus SoundSupport: Limitation on use

No limitation on use

Program

Start-up volume
(Tinnitus)

Max volume
(Tinnitus)

1 Max

hours
per day

Max

hours
per day

2 Max

hours
per day

Max

hours
per day

3 Max

hours
per day

Max

hours
per day

4 Max

hours
per day

Max

hours
per day

190430/UK

Ref. OSHA (Occupational Safety & Health Administration,
U.S. department of Labour) / DIRECTIVE 2003/10/EC on
the minimum health and safety requirements regarding the
exposure of workers to the risks arising from physical
agents (noise) / Occupational exposure to noise: evaluation,
prevention and control – Special Report S 64, WHO.

< 15 mm >

< >

8,15 mm

< >

9.0 mm

< 19 mm >

Placeholder

for FSC logo

Manufacturer:

Bernafon AG
Morgenstrasse 131
3018 Bern
Switzerland
www.bernafon.com

New Zealand

Bernafon New Zealand
Millennium Centre
Level 2, Building A
600 Great South Road
Greenlane, Auckland 1051
Toll Free 0800 442 257
[e-mail]

South Africa

Bernafon South Africa (Pty) Ltd
39 Van Vuuren Street
Constantia Kloof
1709
Phone + 27 11 675 6104

Australia

Bernafon Australia
629 Nudgee Road
Nundah QLD 4012
Freecall 1800 809 111
Phone [phone]
[e-mail]

United Kingdom

Bernafon UK
Cadzow Industrial Estate
Off Low Waters Road
Hamilton
ML3 7QE Scotland
Phone + 44 1698 285 968
[e-mail]

0000190430000001

2018- 03-14/190430/UK /Firmware 3.x or earlier/subject to change