Bernafon Viron 3-1 miniRITE Instructions for use

miniRITE

Receiver-in-the-Ear Hearing Aids

VIRON

ZERENA

Instructions for Use

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 get the most out 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.

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Model overview

This booklet is valid for the following hearing aid families and models:

Viron FW4

Viron 9 – VN9 MNR

GTIN: (01)05711584106501

Viron 7 – VN7 MNR

GTIN: (01)05711584106495

Viron 5 – VN5 MNR

GTIN: (01)05711584106488

Viron 3 – VN3 MNR

GTIN: (01)05711584115916

Viron 1 – VN1 MNR

GTIN: (01)05711584115923

Zerena FW3

Zerena 9 – ZR9 MNR

GTIN: (01)05711584090350

Zerena 7 – ZR7 MNR

GTIN: (01)05711584090275

Zerena 5 – ZR5 MNR

GTIN: (01)05711584090299

Zerena 3 – ZR3 MNR

GTIN: (01)05711584090336

Zerena 1 – ZR1 MNR

GTIN: (01)05711584090312

Zerena FW2

Zerena 9 – ZR9 MNR

GTIN:(01)05711584085028

Zerena 7 – ZR7 MNR

GTIN: (01)05711584085011

Zerena 5 – ZR5 MNR

GTIN: (01)05711584085035

Zerena FW1

Zerena 9 – ZR9 MNR

GTIN: (01)05711584081457

Zerena 7 – ZR7 MNR

GTIN: (01)05711584081464

Zerena 5 – ZR5 MNR

GTIN: (01)05711584081433

The following acoustic options are available for the above families:

60-Speaker

85-Speaker

100-Speaker (power instrument)

100-Speaker with Power Mold (power instrument)

105-Speaker with Power Mold (power instrument)

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Intended use

Intended use

The hearing aid is intended to amplify and transmit sound to the ear

Indications for use

Impaired hearing within mild to severe-to-profound hearing loss

Intended user

Adults and children older than 36 months

Use environment

Indoor and outdoor

Contraindications

Users of active implants must pay special attention when using the hearing aid. For more information read the Warnings section.

Clinical benefits

The hearing aid is designed to provide better speech understanding to help ease communication with the aim of improving quality of life

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Important notice

The hearing aid amplification is uniquely adjusted and optimized to your hearing capabilities during the hearing aid fitting performed by your hearing care professional.

Table of contents

Identify your hearing aid, speaker, and earpiece 10

Your hearing aid − What it is 13

What it does

Identify left and right hearing aid

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15

Battery (size 312)

Turn the hearing aid ON and OFF

When to replace a battery

Replace the battery

16

17

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19

Put on the hearing aid

Caring for your hearing aid

Replace dome or Grip Tip

ProWax miniFit filter

Clean Micro Mold, Lite Tip, or Power Mold

Replace ProWax filter

Flight mode

Optional features and accessories

Change volume (optional)

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31

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8

Change program (optional)

Mute the hearing aid (optional)

Quick reset and pairing mode

Using hearing aid with iPhone, iPad, and iPod touch

Pairing hearing aid with iPhone

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37

Re-connect your hearing aids to your iPhone, iPad, or iPod touch 40

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Wireless accessories (optional)

Other options (optional)

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42

Tinnitus SoundSupport (optional)

Guidelines for tinnitus sound generator users

43

Sound options and volume adjustment

Limitation on use time

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47

Important information for hearing care professionals about Tinnitus SoundSupport 48

Warnings related to Tinnitus SoundSupport 50

General warnings 51

Troubleshooting guide 58

Water & dust resistance (IP68)

Conditions of use

Warranty certificate

International warranty

Technical information

Your individual hearing aid settings

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Identify your hearing aid, speaker, and earpiece

Ear grip

(optional)

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Speaker

(60-Speaker shown)

Speakers

miniRITE hearing aid comes with 5 different speakers:

Standard speakers

60-Speaker 85-Speaker 100-Speaker

Power Mold speakers

100-Speaker

105-Speaker

Standard earpieces

The standard speakers use one of the following earpieces:

Open Dome

Bass Dome, single vent

Bass Dome, double vent

Power Dome

Grip Tip

(available in small and large, left and right, with or without vent)

Please see details for replacing the dome or Grip Tip in section: “Replace dome or Grip Tip”.

Dome sizes

5 mm* 6 mm 8 mm 10 mm

* only as Open Dome for 60-Speaker

** not for Open Dome

12 mm**

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Customized earpieces

Micro Mold

Lite Tip

VarioTherm

®

Micro Mold

VarioTherm

®

Lite Tip

VarioTherm ® is a registered trademark of Dreve.

Your hearing aid − What it is

Microphone openings

Ear grip

(optional)

Wax filter

Push button

Speaker

(60-Speaker shown)

Battery drawer

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What it does

Sound in

Holds the speaker in place

Wax protection of speaker

Sound out

Change program and volume, and mute the hearing aid

Contains the battery.

Battery drawer is also the on/off switch.

Identify left and right hearing aid

It is important to distinguish between the left and the right hearing aid as they might be programmed differently. You can find left/right color indicators in the battery drawer, on 60- and 85-Speakers.

Indicators can also be found on 100-Speakers and some earpieces.

A

RED

indicator marks the

RIGHT hearing aid

A

BLUE

indicator marks the

LEFT hearing aid

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Battery (size 312)

Your hearing aid is a miniature electronic device that runs on special batteries. To activate the hearing aid, you must insert a new battery in the battery drawer.

See how in the “Replace the battery” section.

Make sure the plus is visible

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Battery drawer Pull out to open

Turn the hearing aid ON and OFF

The battery drawer is used to switch the hearing aid on and off. To save battery life, make sure your hearing aid is switched off when you are not wearing it.

Turn ON

Close the battery drawer with the battery in place.

Turn OFF

Open the battery drawer.

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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.

Three beeps*

= The battery is running low

Four beeps

= The battery has run 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.

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* Bluetooth ® will be shut down and is not 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.

✻

The batteries need to be replaced more often if you are streaming audio or music to your hearing aid.

Replace the battery

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 function.

3. Insert

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

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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.

Put on the hearing aid

The speaker brings the sound into your ear. The speaker should always be used with an earpiece attached. Use only parts designed for your hearing aid.

If the speaker has an ear grip, place it in the ear so it follows the contour of the ear (see step 3).

Step 1

Place the hearing aid behind your ear.

Step 2

Hold the bend of the speaker wire between your thumb and index finger. The earpiece should point towards the ear canal opening.

Step 3

Gently push the earpiece into your ear canal until the speaker wire sits close against the side of your head.

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MultiTool for handling batteries and cleaning

The MultiTool contains a magnet which 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.

Magnet

Wire loop

Brush

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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.

Caring for your hearing aid

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

Clean the microphone openings

Carefully brush away debris from the openings using a clean brush. Gently brush the surface and make sure the brush is not pressed into the openings.

Microphone openings

Wax filter

Important notice

Use a soft, dry cloth to clean the hearing aid.

It must never be washed or immersed in water or other liquids.

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Replace dome or Grip Tip

The earpiece (dome or Grip Tip) should not be cleaned.

If the earpiece is filled with wax, replace it with a new one. Grip Tip should be replaced at least once a month.

Step 1

Hold on to the speaker and then pull off the earpiece.

Step 2

Insert the speaker exactly into the middle of the earpiece to obtain a firm attachment.

Step 3

Push firmly to ensure that the earpiece is fastened securely.

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Important notice

If the earpiece is not on the speaker when removed from the ear, the earpiece might still be in the ear canal. Consult your hearing care professional for further instructions.

ProWax miniFit filter

The speaker has a white wax filter attached to the end where the earpiece is attached. The wax filter will help prevent wax and debris from damaging the speaker. If the filter becomes clogged, please replace the wax filter (see section “Replace ProWax miniFit filter”) or contact your hearing care professional.

Remove the earpiece from the speaker before replacing the wax filter.

Important notice

Always use the same type of wax filter as was originally supplied with the hearing aid. If you are in any doubt about the use or replacement of wax filters, contact your hearing care professional.

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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 wax filter.

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2. Remove

Push the empty pin into the wax filter in the speaker and pull it out.

New filter

Empty pin

3. Insert

Insert the new wax filter using the other pin, remove the tool and throw it out.

New filter

Old filter

4. Final

The speaker should look as shown when you have replaced the wax filter.

✻

If you use a mold, a hearing care professional must replace the wax filter in the speaker.

Clean Micro Mold, Lite Tip, or Power Mold

The earpiece should be cleaned regularly. The earpiece contains a wax filter which should be replaced when clogged or when the hearing aid does not sound normal.

Always use the wax filter delivered by your hearing care professional.

The vent is cleaned by pressing the brush through the hole, twisting it slightly.

Vent

ProWax filter*

* VarioTherm

®

Micro Mold and Lite Tip do not have a wax filter.

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Replace ProWax filter

1. Tool

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

2. Remove

Push the empty pin into the wax filter in the mold and pull it out.

New filter

New filter

3. Insert

Insert the new wax filter using the other pin, remove the tool, and throw it out.

Old filter

Flight mode

When boarding an airplane or entering an area where it is prohibited to radiate radio signals, e.g., during flight, flight mode must be activated. The hearing aid will still be working. It is only necessary to activate flight mode on one hearing aid.

To activate and deactivate flight mode

Press the push button for at least 7 seconds. A jingle confirms your action.

Opening and closing the battery drawer will deactivate the flight mode. See section “Quick reset”.

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Optional features and accessories

The features and accessories described on the following pages are optional. Please contact your hearing care professional to find out how your hearing aid is programmed. If you experience difficult listening situations, a special program may be helpful. These are programmed by your hearing care professional.

Write down hearing situations where you may need help.

Change volume (optional)

When you have two hearing aids, the push button allows you to adjust the volume in both ears. You will 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

Maximum

Start-up level

You will hear 2 beeps at the start-up level.

You will hear 3 beeps at

Maximum and Minimum.

Minimum

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Change program (optional)

Your hearing aid can have up to 4 different programs.

These are programmed by your hearing care professional.

Press the button to change program

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✼

If you have two hearing aids, the RIGHT hearing aid switches forwards from, for example, program 1 to 2 and the LEFT hearing aid switches backwards from, for example, program 4 to 3.

To be filled out by the hearing care professional

Program Activation sound When to use

1 “1 beep”

2

3

4

“2 beeps”

“3 beeps”

“4 beeps”

Program change: Medium press Short press

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Mute the hearing aid (optional)

Use the mute function if you need to silence the hearing aid while wearing it.

Apply a very long press

(4 seconds) to the button to mute the hearing aid.

To reactivate, push the button briefly.

Your hearing aid can be muted by using one of the following optional devices:

·

·

Bernafon EasyControl-A app

SoundClip-A

·

RC-A remote control

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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.

Quick reset and pairing mode

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. A jingle is played when you reset the hearing aid.

To pair your hearing aid with a wireless accessory, your hearing aid must be put into pairing mode.

This can be done by opening and closing the battery drawer. The hearing aid will remain in pairing mode for 180 seconds. All compatible accessories are listed in chapter “Wireless accessories”.

Open Close

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Using hearing aid with iPhone, iPad, and iPod touch

Your hearing aid is a Made for iPhone

®

hearing aid and allows 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.

For information on compatibility, please visit www.bernafon.com/products/accessories.

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✼

Direct audio streaming is currently not supported by

Android™.

Pairing hearing aid with iPhone

2. Accessibility 1. Settings

Bluetooth

On

MFi Hearing Devices

Accessibility

Open your iPhone and go to “Settings”.

Make sure Bluetooth

®

is on. Then choose

“Accessibility”.

On the “Accessibility” screen, choose

“MFi Hearing Devices”.

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3. Prepare 4. Select

Andrea’s Hearing Devices

Bernafon Viron 9

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Open and close the battery drawer, on both hearing aids if you have two and place it close to your iPhone. The hearing aid stays in pairing mode for 3 minutes.

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

5. Confirm pairing

Bluetooth

Pairing Request

Bernafon Viron would like to pair with your iPhone

Cancel Pair

Confirm pairing.

If you have two hearing aids, pairing confirmation is needed for each hearing aid.

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

When you turn off your hearing aids, iPhone, iPad, or iPod touch, these will no longer be connected.

To connect them again, turn on your hearing aids by opening and closing the battery drawer. The hearing aids will then automatically re-connect to your device.

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Use of the Made for Apple badge means that an accessory has been designed to connect specifically to the Apple product(s) identified in the badge, and has been certified by the developer to meet Apple performance standards. Apple is not responsible for the operation of this device or its compliance with safety and regulatory standards. Please note that the use of this accessory with iPod, iPhone, or iPad may affect wireless performance.

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

The app offers an intuitive and discreet way to control your hearing aids with iPhone, iPad, iPod touch, and

Android devices.

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

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Other options (optional)

Auto Telephone

(optional for Zerena)

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.

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For more information, please contact your hearing care professional.

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.

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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 sufficient 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 identified and treated prior to using a sound generator.

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.

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.

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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.

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 first 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 filled out by your hearing care professional.

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.

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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 fitting software will automatically display a warning when the hearing aid exceeds

80 dB(A) SPL. See “max wearing time” indicator next to the tinnitus fitting graph in the fitting 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.

If the volume control is activated

A warning may be displayed if you activate the tinnitus volume control in the “Local Controls” 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 fitting 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.

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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.

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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.

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 benefit 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.

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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 difficulties.

If a battery, hearing aid or small part 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.

General warnings

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 (e.g. when you are in traffic). 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

·

The hearing aid has been thoroughly tested and characterized for human health according to international standards for human exposure

(Specific Absorption Ratio – SAR), induced electromagnetic power and voltages into the human body. The exposure values are well below international accepted safety limits for SAR, induced electromagnetic power and voltages into the human body defined in the standards for human health and coexistence with active medical implants as pacemakers and heart defibrillators.

·

The Auto Telephone magnet and the MultiTool

(which has a built-in magnet) should be kept more than 30 cm away from the implant, e.g. 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.

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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 electromagnetic fields.

Heat and chemicals

·

The hearing aid must never be exposed to extreme heat e.g. 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, fitting 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.

General warnings

Possible side effects

·

Hearing aids, molds or domes may cause an accelerated accumulation of earwax.

·

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.

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 wireless 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, flight mode must be activated or the hearing aid needs to be turned off, unless Bluetooth

®

is specifically permitted by the flight personnel.

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Connection to external equipment

·

The safety of the hearing aid when connected to external equipment with an auxiliary input cable and/or with a 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.

Consult your hearing care professional if you experience unexpected operations or serious incidents with your hearing aid during use or because of its use. Your hearing care professional will support you with issue handling and, if relevant, reporting to the manufacturer and/or the national authorities.

Your hearing aid is only a part of hearing habilitation and may need to be supplemented by auditory training and instruction in lipreading.

Only use your hearing aid in areas where wireless transmission is permitted.

Modification of hearing aids is not allowed

Changes or modifications not expressly approved by the manufacturer will void the warranty of the equipment.

Incompatible non-supplied accessories

Only use accessories, transducers or cables supplied by the manufacturer. Incompatible accessories may result in reduced electromagnetic compatibility

(EMC) of your device.

Electromagnetic interference may occur in the vicinity of equipment with the symbol to the right. Portable and mobile RF (radio frequency) communications equipment can affect the performance of your hearing aid. If your hearing aid is affected by electromagnetic interference, move away from the source to reduce the interference.

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Troubleshooting guide

Symptom

No sound

Intermittent or reduced sound

Squealing noise

Beeping

Possible causes

Dead battery

Clogged earpieces

(dome, Grip Tip, Micro Mold, or Lite Tip)

Clogged sound outlet

Moisture

Dead battery

Hearing aid earpiece inserted incorrectly

Ear wax accumulated in ear canal

If your hearing aid plays

8 beeps, 4 times consecutively, your hearing aid needs a microphone service check

Pairing issue with Apple device

Bluetooth

®

connection failed

Only one hearing aid paired

Solutions

Replace the battery

Clean mold

Consider replacing wax filter, dome, or Grip Tip

Clean mold or replace wax filter, dome, or Grip Tip

Wipe battery with a dry cloth

Replace the battery

Re-insert the earpiece

Have ear canal examined by your doctor

Contact your hearing care professional

1. Unpair your hearing aids

(Settings g

Accessibility g

MFi 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 aid with iPhone”).

Troubleshooting guide

Symptom

No sound

Intermittent or reduced sound

Squealing noise

Beeping

Possible causes

Dead battery

Clogged earpieces

(dome, Grip Tip, Micro Mold, or Lite Tip)

Clogged sound outlet

Moisture

Dead battery

Hearing aid earpiece inserted incorrectly

Ear wax accumulated in ear canal

If your hearing aid plays

8 beeps, 4 times consecutively, your hearing aid needs a microphone service check

Pairing issue with Apple device

Bluetooth

®

connection failed

Only one hearing aid paired

Solutions

Replace the battery

Clean mold

Consider replacing wax filter, dome, or Grip Tip

Clean mold or replace wax filter, dome, or Grip Tip

Wipe battery with a dry cloth

Replace the battery

Re-insert the earpiece

Have ear canal examined by your doctor

Contact your hearing care professional

1. Unpair your hearing aids

(Settings g

Accessibility g

MFi 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 aid with iPhone”).

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

59

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.

60

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.

Notes

61

62

Conditions of use

Operating conditions

Storage and transportation conditions

Temperature:

+1 °C to +40 °C

Relative humidity:

5 % to 93 %, non-condensing

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

Warranty certificate

Name of owner:

Hearing care professional:

Hearing care professional address:

Hearing care professional phone:

Purchase date:

Warranty period:

Model right:

Model left:

Month:

Serial no.:

Serial no.:

63

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 filters, 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.

64

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.

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 field strength of the transmitter is very weak and is always below 15 nW

(–40 dBμA/m at 10 meter distance).

The hearing aid also contains a radio transceiver using Bluetooth

®

Low Energy (BLE) and a proprietary shortrange radio technology, both working at

2.4 GHz. The radio transmitter is weak and is always below 3 mW equal to 4.8 dBm 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 Sheet on www.bernafon.com.

65

USA and Canada

The hearing aid contains a radio module with the following certification ID numbers:

FCC ID: U6XAUMRIT

IC: 7031A-AUMRIT

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

3018 Bern

Switzerland

66

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

E2105

Your individual hearing aid settings

To be filled out by your hearing care professional

Left

Settings overview for your hearing aid

Right

Volume control

Program shift

Mute

Tinnitus SoundSupport

Volume control indicators

Beeps at min/max volume

Clicks when changing volume

Beeps at preferred volume

Battery indicators

Low battery warning

67

68

Description of symbols used in this booklet or on the packaging label

E2105

IP68

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 defined 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 identification of the notified 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.

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.

Bluetooth

®

logo

Registered trademark of Bluetooth

®

SIG, Inc. where any use of such requires a license.

REF

SN

Made for iPod, iPhone, and iPad

Indicates that the device is compatible with iPod, iPhone, and iPad.

Keep dry

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

Caution symbol

Consult instructions for use for warnings and cautions.

Catalogue number

Indicates the manufacturer’s catalogue number so that the medical device can be identified.

Serial number

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

Medical Device

The device is a medical device.

Radio Frequency (RF) transmitter

Your hearing aid contains an RF transmitter.

GTIN

Global Trade Item Number

A globally unique 14-digit number used to identify medical device products including medical device software. GTIN in this booklet is related to medical device firmware (inside the hearing aid). GTIN on regulatory packaging label is related to medical device hardware (the hearing aid itself).

69

Tinnitus SoundSupport: Limitation on use

No limitation on use

Program

Start-up volume

(Tinnitus)

1 Max

Max volume (Tinnitus) hours per day Max hours per day

2 Max hours per day Max hours per day

3

4

Max hours per day Max hours per day

Max hours per day Max hours per day

70

214766/UK

Placeholder for FSC logo

< 15 mm >

< >

8,15 mm

UK ab Zerena OHNE Canada - 28.07.2017 aoho

Manufacturer:

Bernafon AG

Morgenstrasse 131

3018 Bern

Switzerland www.bernafon.com

0000214766000001