Bernafon Alpha IIC, CIC, ITC, ITE HS, ITE FS Instructions for use
Reklamë
Reklamë
Instructions for use
I
Alpha
Model overview
This booklet is valid for the Bernafon Alpha family in the following hearing aid models, battery sizes, and styles:
FW 1.4
Bernafon Alpha 9
Bernafon Alpha 7
Bernafon Alpha 5
Bernafon Alpha 3
Bernafon Alpha 1
Battery size
10 312
Bluetooth®
Yes
No
GTIN: (01) 05714464059850
GTIN: (01) 05714464059867
GTIN: (01) 05714464059874
GTIN: (01) 05714464059881
GTIN: (01) 05714464059898
Styles
IIC
CIC
ITC
ITE HS
ITE FS
Invisible-In-the-Canal
Completely-In-the-Canal
In-the-Canal
In-the-Ear Half Shell
In-the-Ear Full Shell
Introduction to this booklet
This booklet guides you on how to use and maintain your new hearing aids.
Ensure you read the booklet carefully including the Warnings section. This will help you get the most benefit of your new hearing aid.
Your hearing care professional has adjusted the hearing aid to meet your needs. If you have additional questions, contact your hearing care professional.
A hearing care professional* (hearing aid professional, audiologist, ENT
(ear, nose and throat) doctor, and hearing aid dispenser) is a person who is appropriately educated and has proven competency in professionally assessing hearing, selecting, fitting, and delivering hearing instruments and rehabilitation care to persons with hearing loss.
The education of the hearing care professional is in accordance with national or regional regulations.
*The job title may vary from country to country.
For your convenience this booklet contains a navigation bar to help you navigate easily through the different sections.
About Getting started Daily use Options Tinnitus Warnings More info
Intended use
Intended use
Indications for use
The hearing aid is intended to amplify and transmit sound to the ear.
Bilateral or unilateral impaired hearing of sensorineural, conductive, or mixed type ranging from a slight (25 dB HL*) to severe (80 dB HL*) degree of hearing loss, with an individual frequency configuration.
Intended user
Intended user group Adults.
Use environment Indoor and outdoor.
Contraindications
Person with hearing loss using a hearing aid and their caregivers. Hearing care professional responsible for adjusting the hearing aid.
Clinical benefits
Not suitable for infants below 36 months.**
Users of active implants must pay special attention when using the hearing aid. For more information read the
Warnings section.
The hearing aid is designed to provide better speech understanding to help ease communication with the aim of improving quality of life.
* As specified by the American Speech-Language-Hearing Association, asha.org, using pure-tone average of
0.5, 1 and 2 kHz.
** In accordance with current Pediatric Amplification guidelines, custom hearing aids are not typically considered for children of any age. However, a hearing care professional may, in special circumstance and on a case-bycase basis, select them for children older than 36 months.
IMPORTANT NOTICE
The hearing aid amplification is uniquely adjusted and optimised to your personal hearing capabilities during the hearing aid fitting performed by your hearing care professional.
Table of contents
MultiTool for handling batteries and cleaning
Turn the hearing aid ON and OFF
Hearing aids with size 10 battery
Hearing aids with size 312 battery
Identify left and right hearing aid
Change volume with push-button
Change volume with volume wheel
Use hearing aids with iPhone, iPad, and iPod touch
Use your hearing aids with Android devices
Optional features and accessories
Tinnitus SoundSupport™ (optional)
Guidelines for Tinnitus SoundSupport users
Sound options and volume adjustment
Important information for hearing care professionals about
Warnings related to Tinnitus 52
Continues on next page
Table of contents
Your individual hearing aid settings
About
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.
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Hearing aids with size 10 battery
(CIC shown)
What it is and does
Microphone inlet
Sound in
Push-button
(optional)
Mute, change volume and program
Battery drawer
Contains the battery and functions as
ON/OFF switch
Pull out string
Pull out the hearing aid
Vent
Components may be positioned differently on your hearing aid.
Sound outlet
Sound out
Vent
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Hearing aids with size 312 battery
(ITC shown)
What it is and does
Push-button
(optional)
Mute, change volume and program
Volume wheel
(optional)
Change volume
Sound outlet
Sound out
Battery drawer
Contains the battery and functions as
ON/OFF switch
Vent
Microphone inlet
Sound in
Vent
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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 identifies the LEFT hearing aid
A RED shell, dot or text identifies the RIGHT hearing aid
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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 earwax. If the vent is very small, a special tool may be required. If you need a new tool please contact your hearing care professional.
Magnet Wire loop
Brush
IMPORTANT NOTICE
The MultiTool has a built-in magnet. Keep the MultiTool at least 30 centimetres
(1 foot) away from credit cards and other magnetically sensitive devices.
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Getting started
Turn the hearing aid ON and OFF
The battery drawer is also 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. If you wish to return to the standard settings of the hearing aid, simply open and then close the battery drawer (quick reset).
Turn ON
Close the battery drawer with the battery in place.
Turn OFF
Open the battery drawer.
Note: Open the battery door fully to make sure the hearing aid does not drain the battery fully and to allow air to circulate whenever you are not using your hearing instrument, especially at night or for longer periods of time.
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Replace the 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.
* If your hearing aid has Bluetooth® this will be turned off and it will not be possible to use wireless accessories.
Note: Batteries need to be replaced more often if you are streaming audio or music to your hearing aids.
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How to replace the battery
1. Remove 2. Uncover 3. Insert
Fully open the battery drawer. Remove the battery.
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.
Insert the new battery into the battery drawer.
Ensure that the + side of the battery and battery drawer align.
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4. Close Tip
Close the battery drawer. The hearing aid will play a jingle.
Hold the hearing aid close to your ear to hear the jingle.
MultiTool
The MultiTool can be used for battery change. Use the magnetic end to remove and insert batteries.
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Daily use
Insert the hearing aid
Step 1 Step 2
Place the tip of the hearing aid in your ear canal.
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 fi ts comfortably in the ear.
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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 aids, as it is not designed for this purpose.
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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 filters do not fall off.
Microphone inlets
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Clean the vent by pressing the brush through the hole while twisting it slightly.
If the vent is very small, a special tool may be required.
Please consult your hearing care professional.
Vent
Vent
IMPORTANT NOTICE
To clean the hearing aids, use a soft, dry cloth. The hearing aids must never be washed or immersed in water or other liquids.
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Filter replacement
The filters keep wax and debris from damaging the hearing aid.
If the filters becomes clogged, please replace the filters or contact your hearing care professional.
• ProWax miniFit filter 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 filters.
IMPORTANT NOTICE
Ensure you always use the same type of wax filter as was originally supplied with the hearing aids.
If you are in doubt about the use or replacement of ProWax miniFit filters, contact your hearing care professional.
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Replace ProWax miniFit fi lter
1. Tool 2. Remove
New fi lter
Remove the tool from the shell. The tool has two pins, one empty for removal and one with the new ProWax miniFit fi lter.
New fi lter
Old fi lter
Push the empty pin into the ProWax miniFit fi lter in the hearing aid and pull it out.
3. Insert
New fi lter
Old fi lter
Insert the new ProWax miniFit fi lter using the other pin, remove the tool and throw it out.
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Replace T-Cap fi lter
(hearing aids with size 10 battery)
1. Tool 2. Remove new fi lter
3. Insert
Remove the tool from the packaging. The tool has two ends, one for removal and one with the new T-Cap fi lter.
Push the tool fork under the top edge of the used T-Cap fi lter and lift it out.
Insert the new T-Cap fi lter and remove the tool by twisting it slightly. Throw the tool out after use.
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Replace O-Cap fi lter
(hearing aids with size 312 batteries)
1. Tool 2. Remove new fi lter
3. Insert
Remove the tool from the packaging. The tool has two ends, one for removal and one with the new O-Cap fi lter.
Push the pointed end of the tool into the existing O-Cap fi lter and pull it out.
Insert the new O-Cap fi lter using the other end of the tool and remove.
Throw the tool out after use.
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Change programs
Your hearing aid can have up to 4 diff erent 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 synchronised hearing aids (both hearing aids respond when either push-button is operated), the RIGHT hearing aid switches forward from e.g., program 1 to 2 and the LEFT hearing aid switches backwards from e.g., program 4 to 3.
If your hearing aids work independently, you must press the buttons on each hearing aid.
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To be filled out by the hearing care professional
Program Sound you will hear when activated
When to use
1 “1 beep”
2
3
4
“2 beeps”
“3 beeps”
“4 beeps”
Independent
LEFT
Short press
Program change:
Synchronised
RIGHT
Long press
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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
MAXIMUM
START-UP
VOLUME
MINIMUM
To be fi lled out by the hearing care professional
Volume change LEFT RIGHT
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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.
Down Up
Turn forward to turn up volume
Turn backwards to turn down the volume
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Options
Mute the hearing aid
Use the mute function if you need to silence the hearing aid. Only available for hearing aids with push-button.
Apply a very long press
(> 2.4 seconds) to the pushbutton to mute the hearing aid. To reactivate the hearing aid, push the button briefl y.
NOTE: the mute function only mutes the microphone(s) on the hearing aids.
IMPORTANT NOTICE
Do not use the mute function as an off switch, as the hearing aids are still using battery power in this mode.
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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, e.g. during fl ight, fl ight mode must be activated.
The hearing aid will still be working. It is only necessary to activate fl 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 confi rms your action.
Opening and closing the battery drawer will also deactivate fl ight mode.
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Use hearing aids with iPhone, iPad, and iPod touch
Your hearing aids are Made for iPhone® and allow for direct communication and control with iPhone, iPad® or iPod touch®.
For assistance in using these products with your hearing aids, contact your hearing care professional or visit: www.bernafon.com/products/accessories
To see how to pair your hearing aids with your iPhone visit: www.bernafon.com/hearing-aid-users/support/library
For information on compatibility, visit: www.bernafon.com/hearing-aidusers/hearing-aids/connectivity/compatibility
Use of the Made for Apple badge means that an accessory has been designed to connect specifically to the Apple products 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.
Note that use of this accessory with iPod, iPhone, or iPad may affect wireless performance.
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Use your hearing aids with Android devices
Your hearing aids support Audio Streaming for Hearing Aids (ASHA) and allow for direct streaming from selected Android™ devices.
For assistance in using your hearing aids with Android devices, contact your hearing care professional or visit: www.bernafon.com/products/accessories
To see how to pair your hearing aids with your Android device visit: www.bernafon.com/hearing-aid-users/support/library
For information on compatibility, visit: www.bernafon.com/hearing-aidusers/hearing-aids/connectivity/compatibility
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Wireless accessories
As an enhancement to your hearing aids, a range of wireless accessories are available. These can enable you to hear and communicate better in many everyday situations.
SoundClip-A
When paired with your mobile phone, you can use the hearing aids as a hands-free headset, or as a remote microphone.
RC-A
Offers the ability to change program, adjust volume, or mute your hearing aids.
TV-A
Wireless transmitter of sound from TV and electronic audio devices. TV Adapter streams sound directly to your hearing aids.
EasyControl-A app
An application that lets you control your hearing aid from your mobile phone or tablet. For iPhone, iPad, iPod touch, and Android™ devices.
Ensure that you only download and install the app from the official app stores.
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For more information visit: www.bernafon.com/products/accessories
Apple, the Apple logo, iPhone, iPad, and iPod touch 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.
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Other options
Telecoil - optional for select styles
Telecoil helps you hear better when using a telephone with a builtin loop or when you are in buildings with teleloop systems such as theatres, churches, or lecture rooms. This symbol or a similar sign is shown wherever a teleloop has been installed.
For more information, please contact your hearing care professional.
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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 any hearing situations in which you may need help.
Tinnitus
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
Only available for CIC, ITC, ITE HS and ITE FS hearing aids with a pushbutton. Please see the Model overview section to find out which style your hearing aid is.
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Guidelines for Tinnitus SoundSupport 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 have 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”.
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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 or volume wheel 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.
Change volume with push-button
See section Change volume with push-button for illustration
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.
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Change volume with volume wheel
See section Change volume with volume wheel for illustration
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 filled out by your hearing care professional.
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 RC-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.
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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” in the section Your individual hearing aid settings at the end of this booklet to learn how many hours per day you can safely use the relief sound in your hearing aids.
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.
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If the volume control is activated
A warning may be displayed if you activate the tinnitus volume control in the “Buttons and Indicators” screen. This occurs if the relief sound can be listened to at levels that may cause hearing damage. The “Max wearing time” 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.
Warnings related to Tinnitus
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 unauthorised use and to keep the device out of reach of children and pets.
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.
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Warnings
General warnings
For your personal safety and to ensure correct usage, you should familiarise yourself fully with the following general warnings before using your hearing aids.
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.
Note that hearing aids do not restore normal hearing and do not prevent or improve a hearing impairment resulting from organic conditions.
Hearing aids are only a part of hearing habilitation and may need to be supplemented by auditory training and instruction in lipreading.
Furthermore, note that in most cases, infrequent use of a hearing aids does not permit a user to attain full benefit from it.
Usage of hearing aids
Hearing aids should only be used 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.
Choking hazards and risk of swallowing batteries or 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.
If a battery, hearing aid or small part is swallowed, see a doctor immediately.
Continues on next page
General warnings
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.
Dysfunction
Be aware of the possibility that your hearing aids 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 earwax.
Active implants
The hearing aid has been thoroughly tested and characterised 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, such as pacemakers and heart defibrillators.
The Autophone magnet or MultiTool (which has a built-in magnet) should be kept more than 30 centimetres (1 foot) away from the implant, e.g. do not carry it in your breast pocket. Follow the guidelines recommended by the manufacturers of implantable defibrillators and pacemakers on use with magnets.
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If you have an active brain implant, contact the manufacturer of your implantable device for information about the risk of disturbance.
X-ray/CT/MR/PET scanning, electrotherapy and surgery
Remove your hearing aid before X-ray examinations and CT/MR/PET scans, 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 hearing aid
Special care should be exercised in selecting, fitting, and using a hearing aids where the maximum sound pressure capability exceeds 132 dB SPL
(IEC 60318-4 / IEC 711), as there may be a risk of impairing the remaining hearing of the hearing aid user. For information on whether your instrument is a power hearing aid, see the Your individual hearing aids settings section in this booklet.
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General warnings
Possible side effects
Hearing aids and earpieces may cause an accelerated accumulation of earwax.
The non-allergenic materials used in hearing aids may, in rare cases cause a skin irritation or other side effects.
If these conditions occur, seek consultation with a physician .
Use on aircraft
If your hearing aids have Bluetooth wireless technology, when on board an aircraft, the hearing aids must be put into flight mode to deactivate Bluetooth, unless Bluetooth is permitted by the flight personnel.
The hearing aid needs to have a pushbutton for you to be able to activate flight mode, otherwise you must turn off your hearing aids.
To find out whether your hearing aids have Bluetooth wireless technology, see the model overview in your hearing aids’
Instructions for use.
Connection to external equipment
The safety of the hearing aids, when connected to external equipment (with an auxiliary input cable and/or with USB cable and/or directly), is determined by the external signal source. When the hearing aid is connected to external equipment which is plugged into a power socket, this equipment must comply with IEC 62368-1 or equivalent safety standards.
Use of third-party accessories
Only use accessories, transducers, or cables supplied by the manufacturer. Nonoriginal accessories may result in reduced electromagnetic compatibility (EMC) of your hearing aid.
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Modification of hearing aids is not allowed
Changes or modifications not expressly approved by the manufacturer will void the warranty of the equipment.
Interference
The hearing aids have been thoroughly tested for interference according to the most stringent international standards.
Electromagnetic interference may occur in the vicinity of equipment with the symbol on the left. Portable and mobile RF (radio frequency) communications equipment can affect the performance of the hearing aids. If your hearing aids are affected by electromagnetic interference, move away from the source to reduce the interference.
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More info
Troubleshooting guide
Symptom
No sound
Intermittent or reduced sound
Squealing noise
Pairing issue with Apple device
Possible causes
Worn-out battery
Clogged sound outlet
Clogged microphone inlet
Hearing aid microphone muted
Clogged sound outlet
Moisture
Worn-out battery
Hearing aid not inserted properly
Ear wax accumulated in ear canal
Bluetooth connection failed
Only one hearing aid paired
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Solutions
Replace the battery
Clean sound outlet* or replace the wax filter
Clean microphone inlet* or replace filter (T-Cap or O-Cap)
Unmute the hearing aid microphone
Clean sound outlet or replace the wax filter
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 aid. 2) Turn Bluetooth off and on again. 3) Open and close battery drawer on hearing aid. 4) Re-pair hearing aid (visit www.bernafon.com/hearing-aid-users/support/library)
Symptom
No sound
Intermittent or reduced sound
Squealing noise
Pairing issue with Apple device
Possible causes
Worn-out battery
Clogged sound outlet
Clogged microphone inlet
Hearing aid microphone muted
Clogged sound outlet
Moisture
Worn-out battery
Hearing aid not inserted properly
Ear wax accumulated in ear canal
Bluetooth connection failed
Only one hearing aid paired
Solutions
Replace the battery
Clean sound outlet* or replace the wax filter
Clean microphone inlet* or replace filter (T-Cap or O-Cap)
Unmute the hearing aid microphone
Clean sound outlet or replace the wax filter
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 aid. 2) Turn Bluetooth off and on again. 3) Open and close battery drawer on hearing aid. 4) Re-pair hearing aid (visit www.bernafon.com/hearing-aid-users/support/library)
If none of the above solutions work, consult your hearing care professional for assistance.
* According to guideline in this booklet
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Water & dust resistant (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.
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Conditions of use
Operating Conditions Temperature: +1°C to +40°C (34°F to 104°F)
Humidity: 5% - 93% relative humidity, non-condensing
Atmospheric pressure: 700 hPa to 1060 hPa
Transportation and storage conditions
Temperature and humidity shall not exceed the below limits for extended periods during transportation and storage:
Temperature: -25°C to + 60°C (-13°F to 140°F)
Humidity: 5% - 93% relative humidity, non-condensing
Atmospheric pressure: 700 hPa to 1060 hPa
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Warranty
Certificate
Name of owner: __________________________________________________________
Hearing care professional: __________________________________________________
Hearing care professional’s address: __________________________________________
Hearing care professional’s phone: ___________________________________________
Purchase date: ___________________________________________________________
Warranty period: ________________ Month: __________________________________
Model left: _____________________ Serial no.: ________________________________
Model right: ____________________ Serial no.: ________________________________
Battery size: ____________________________________________________________
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International warranty
Your device is covered by an international warranty issued by the manufacturer.
This international warranty covers manufacturing and material defects in the device 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 unauthorised 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 international warranty and may void it.
The above international warranty does not affect any legal rights that you might have under applicable national legislation governing the sale of consumer goods in the country where you have bought your device. Your hearing care professional may also have issued a warranty that goes beyond the clauses of this international warranty. Please consult him/her for further information.
If you need service
Take your device to your hearing care professional, who may be able to sort out minor problems and adjustments immediately. Your hearing care professional may charge a fee for their services.
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Technical information
The hearing aids contain the following two radio technologies:
The hearing aids contain a radio transceiver using short range magnetic induction technology operating at
3.84 MHz. The magnetic field strength of the transmitter is very weak and always below 15 nW (typically below –40 dBμA/m at a distance of 10 metres (–12.20 dBμA/ ft at a distance of 33 feet).
The hearing aids also contain a radio transceiver using Bluetooth Low Energy and a proprietary, short range radio technology both operating at ISM band
2.4 GHz. The radio transmitter is weak and always below 3 mW equal to 4.8 dBm in total radiated power.
Only use your hearing aids in areas where wireless transmission is permitted.
The hearing aids comply with international standards concerning radio transmitters, electromagnetic compatibility, and human exposure. Due to the limited space available on the hearing aid, relevant approval markings can be found in this booklet. Additional information can be found in the “Product
Information Sheet” on www.bernafon.com
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The manufacturer declares that this hearing aid is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/EU.
This medical device complies with Medical
Device Regulation (EU) 2017/745.
Declaration of Conformity is available at the headquarters.
Bernafon AG
Morgenstrasse 131
3018 Bern
Switzerland www.bernafon.com/doc
SBO Hearing A/S
Denmark
Waste from electronic equipment must be handled according to local regulations.
65
Description of symbols and abbreviations used in this booklet
Warnings
Text marked with a warning symbol must be read before using the device.
Manufacturer
The device is produced by the manufacturer whose name and address are stated next to the symbol. Indicates the medical device manufacturer, as defined in EU Regulation
2017/745.
CE mark
The device complies with all required EU regulations and directives.
The four digit number indicates the identification of the notified body.
Electronic waste (WEEE)
Recycle hearing aids, accessories or batteries according to local regulations.
Hearing aid users can also return electronic waste to their hearing care professional for disposal. Electronic equipment covered by Directive 2012/19/EU on waste and electrical equipment (WEEE).
Regulatory Compliance Mark (RCM)
The device complies with electrical safety, EMC and radio spectrum requirements for devices supplied to the Australian or New Zealand markets.
IP code
Class of protections against harmful ingress of water and particulate matter according to
EN 60529.
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.
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GTIN
Made for Apple badges
Indicates that the device is compatible with iPhone, iPad and iPod touch.
Android badge
Indicates that the device is compatible with Android.
Hearing loop
This logo incorporates the universal symbol for hearing assistance.
The “T” signifies that a hearing loop is installed.
Radio Frequency (RF) transmitter
Your device contains an RF transmitter.
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 (FW).
GTIN on regulatory packaging label is related to medical device hardware.
Firmware
Firmware version used in the device.
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Description of additional symbols used on labels
Keep dry
Indicates a medical device that needs to be protected from moisture.
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.
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Your individual hearing aid settings
To be filled out by your hearing care professional.
Tinnitus SoundSupport: Limitation on use n No limitation on use
Program Start-up volume (Tinnitus)
Max _______ hours per day n 1 n 2 n 3 n 4
Max _______ hours per day
Max _______ hours per day
Max _______ hours per day
Max volume (Tinnitus)
Max _______ hours per day
Max _______ hours per day
Max _______ hours per day
Max _______ hours per day
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Left n Yes n No n Yes n No n Yes n No n Yes n No n On n Off n On n Off n On n Off n On n Off
Power instrument n Yes n No
Settings overview for your hearing aid
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
Right n Yes n No n Yes n No n Yes n No n Yes n No n On n Off n On n Off n On n Off n On n Off
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0000249215000001
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