Beltone 01307000GB-20 Receiver In Ear Hearing Aids

Hearing aid information

earmould
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type| □ Small| □ Small| □ Small|  |
 | □ Medium| □ Medium| □ Medium|  |
 | □Large| □Large| □ Large|  |
Program| Beep| Description
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1| One beep|
2| Two beeps|
3| Three beeps|
4| Four beeps|

Introduction

Thank you for choosing Beltone hearing aids. We recommend that you use your hearing aids every day.

NOTE: Read this booklet carefully BEFORE using your hearing aids.

Intended use
Generic air-conduction hearing aids are wearable sound-amplifying devices intended to compensate for impaired hearing. The fundamental operating principle of hearing aids is to receive, amplify, and transfer sound to the eardrum of a hearing impaired person. The hearing aid is intended to be used by adults and children 12 years of age or older. The hearing aid is intended to be used by lay persons.

For devices including a dome

• The dome is intended to be connected to a receiver tube on the hearing aid. The dome is intended to ensure that the sound outlet of the hearing aid is placed in the ear canal.
• This accessory is intended to be used by the same age group as the hearing aid. The accessory is intended to be used by lay persons.

Getting to know your hearing aid

Rechargeable model

Zinc-Air battery model (312)

Zinc-Air battery model (13)

Domes and earmoulds

Receivers and sport locks

Preparing your hearing aids for use

Battery warnings – all models
WARNING: Batteries are harmful for the environment. Therefore, never try to burn them – dispose of your used batteries according to your country’s regulations or return them to your hearing care professional.

Battery warnings – Rechargeable model

• WARNING:
  • Rechargeable hearing aids are supported by a non-removable rechargeable lithium-ion battery cell. Exposure or ingestion can be seriously harmful.
  • Never put your rechargeable hearing aid in your mouth.
  • Keep your rechargeable hearing aid away from pets, children and people with cognitive, intellectual or mental health challenges.
  • Never swallow lithium-ion batteries nor place them inside any part of the body, as this may lead to fatal injuries in two hours or less. If a lithium-ion battery is swallowed or placed inside any part of the body, or if a rechargeable hearing aid is swallowed, seek immediate medical attention.
  • If the outer casing of your rechargeable hearing aid is broken, the rechargeable batteries inside may leak. In this case, do not attempt to use the hearing aid – contact your hearing care professional.
  • Battery leakage can cause chemical burns. If you get exposed to battery leakage material, rinse immediately with warm water. If you get chemical burns, redness or skin irritation from battery leakage, seek medical attention.

Battery warnings – Zinc-air battery models

• WARNING:
  • Never put a hearing aid battery in your mouth.
  • Keep hearing aid batteries away from pets, children and people with cognitive, intellectual or mental health challenges.
  • Never swallow batteries nor place them inside any part of the body, as the battery can cause serious injuries. If a battery has been swallowed or placed inside any part of the body, seek immediate medical attention.
• CAUTION:
  • Batteries may leak. If you are not going to use your hearing aids for a few days, you MUST remove the batteries.
  • Battery leakage can cause chemical burns. If you are exposed to a battery leakage, rinse immediately with lukewarm water. If you get chemical burns, redness or skin irritation, seek immediate medical attention.
  • Never try to charge zinc-air batteries as this can cause leakage or a small explosion.
    NOTE: Always use new zinc-air batteries that have a minimum remaining shelf life of one year.

Inserting the battery into your hearing aid — Zinc-air battery models

NOTE:

• To save battery power, turn off your hearing aids when they are not in use.
• At night, turn off the hearing aids. Open the battery door completely to allow moisture to evaporate and prolong the hearing aids’ life span.
• If the hearing aids are experiencing frequent loss of connection to wireless accessories, contact your hearing care professional for a list of low impedance batteries.

Charging your hearing aids — Rechargeable model
We recommend that you fully charge your hearing aids before using them. To learn how to charge your hearing aids, please consult the user guide for your hearing aid charger.

Low battery warning (All models)
When the batteries are low on power, your hearing aids reduce the volume, and play a melody every 15 minutes, until they are empty and turn off.
NOTE: Keep spare batteries on hand. (Zinc-air battery models)

Low battery alert when paired with wireless accessories (all models)
NOTE: Your batteries will drain faster when you use wireless functions like streaming from your smart device or from your TV with our TV streamer. As the battery power declines, the wireless functions stop working. A short melody will play every five minutes to let you know that the battery power is low. The table below shows the functionality with different battery charge levels.

These will work again when you insert a new battery (Zinc-air battery models) or charge the hearing aid (Rechargeable model).

Placing your hearing aids in your ears

How to tell left from right
CAUTION: If you have two hearing aids, they may be programmed differently. Do not swap them as this could damage your hearing. Your hearing aids are colour-coded. Left = blue. Right = red. If your hearing aids are not colour coded, ask your hearing care professional to add colour coding.

Inserting the receiver dome into your ear
If your hearing aids have domes, follow these instructions:
NOTE: To avoid whistling, ensure that the wire and dome fit correctly into your ear. If you continue to experience whistling, check the troubleshooting guide for other possible reasons and solutions.

Sport lock
If you are very active, your hearing aids may move from the correct position. To avoid this situation, your hearing care professional can attach and adjust a sport lock to the receiver.
To insert a hearing aid with a sport lock:

1. Insert the hearing aid as usual
2. Tuck the sport lock into the bottom of the concha (the part of your ear just outside the ear canal).

NOTE: Sport locks may become stiff, brittle, or discoloured over time. Contact your hearing care professional for a replacement. Your hearing care professional will help you replace it.

Inserting earmoulds into your ears
If your hearing aids have earmoulds, follow these instructions:
NOTE: When inserting an earmould, it may help to pull your ear up and back with the opposite hand.

Removing your hearing aids from your ears

Removing receiver domes from your ears
If your hearing aids have domes, follow these instructions:

Removing earmoulds from your ears
If your hearing aids have earmoulds, follow these instructions:

Using your hearing aids

Turning your hearing aids on and off
You can turn on your hearing aids either before or after you place them in your ears. Your hearing aids always start on program 1 at the pre-set volume.
Turning your hearing aids on and off — Rechargeable model
To turn your hearing aids on or off, press the push button for 5 seconds. Pressing the button for other lengths of time enables other functions such as flight mode and streaming. These are described elsewhere in this manual.

Explanation of indicator lights:

• One 2-second green blink: The hearing aid turns on and is in operating mode.
• Three 1-second green blinks: The hearing aid turns off.
• When the hearing aid is present in the charger, green indicator lights pulsate: The hearing aid is recharging.

Your hearing aids turn off automatically when you place them in the charger and they turn on automatically when you remove them from the charger.

Turning your hearing aids on and off — Zinc-air battery models

Delayed Activation
Delayed Activation delays the time that your hearing aid turns on after you close the battery door (Zinc-Air battery models) or remove the hearing aids from the charger (Rechargeable model). This function produces a beep for each second of the delay period (either 5 or 10 seconds). Delayed Activation delays when sound comes through your hearing aid. It gives you time to put on the hearing aid without whistling or other issues. If you do not want to use this function, ask your hearing care professional to deactivate it.

Using the push button/multi-function button
These buttons allow you to use a variety of listening programs. Each program is suitable for a different situation.

Listening programs
Your hearing care professional can activate one or more listening programs in your hearing aids. These programs can help you in specific situations. Ask your hearing care professional about which programs could be useful for you.

theatres and places of worship.
Ultra Focus| For use only in very noisy places

(more focused than the Restaurant program).

Apps
We have some apps that you can use to control your hearing aids. You can use these to adjust the volume, change programs and stream from another device.There is more information on these in the Advanced Options chapter.

Using the push button
The “312” models have a push button.

Changing programs

• Push the button to switch from one program to the next. Your hearing aids will beep to confirm the change. The number of beeps indicates which program you have selected.
• To get back to the default listening program, keep scrolling, or turn your hearing aids off and on again.
  NOTE: If you have two hearing aids with synchronisation enabled, a change of program on one hearing aid automatically applies to the second hearing aid as well.

Streaming Sound to your hearing aids
Press the button and keep it pressed for three seconds. Your hearing aids will start streaming from the audio device you have chosen. Before you can stream to your hearing aids, you must pair them with your audio device. For more information on how to do this, consult the user instructions for your audio device.

Using the multi-function button
The “13” models have a multi-funcion button. It is called a multi-function button because it has several functions – you can change program, control volume, and activate streaming.

Changing programs

• To change the program, press the top of the multi-function button and hold it for three seconds. Your hearing aids will beep to confirm the change. The number of beeps indicates which program you have selected.
• Continue pressing it to scroll through the programs available to you.
• To get back to the default listening program, keep scrolling, or turn your hearing aids off and on again.

NOTE: If you have two hearing aids with synchronisation enabled, a change of program on one hearing aid automatically applies to the second hearing aid as well.
This feature can also be configured to allow you to use one hearing aid to increase volume and the other to decrease volume. Any increase or decrease made on one hearing aid will also apply to the other to ensure the volume is the same in both hearing aids.
Your hearing care professional can change the default settings and fill in the table below to record the new settings:

Controlling the volume
If your hearing care professional has activated your volume control, follow these instructions:

Streaming Sound to your hearing aids
Press the bottom part of the button and keep it pressed for three seconds. Your hearing aids will start streaming from the audio device you have chosen. Before you can stream to your hearing aids, you must pair them with your audio device. For more information on how to do this, consult the user instructions for your audio device.

Telecoil (Optional)
Your hearing aid may have a telecoil. The Telecoil function may help to improve understanding of speech with Hearing Aid Compatible (HAC) telephones and in theatres, cinemas, houses of worship, etc. that have a teleloop installed. When you select the Telecoil function, your hearing aid picks up signals from the teleloop or your HAC telephone. Your hearing care professional can activate the Telecoil program.

NOTE:

• The telecoil does not work without a teleloop (that is, an induction loop) or an HAC telephone.
• If you are having trouble hearing with the telecoil, ask your hearing care professional to modify the function.
• If there is no sound from your hearing aids in a teleloop system with an active Telecoil function, the teleloop system may not be turned on or may not be operating correctly.
• The sound from the teleloop and the hearing aid microphones can be mixed according to your preference. Ask your hearing care professional for more details.

Advanced options

Using a telephone
Your hearing aid allows you to use your telephone as you normally do. Finding the optimal position for holding the phone may require practice. The following suggestions may be helpful:

1. Hold the telephone up to your ear canal or hold it close to the hearing aid microphones as illustrated.
2. If you hear whistling, try holding the telephone in the same position for a few seconds. The hearing aid may be able to cancel the whistling.
3. You can also try holding the telephone slightly away from the ear.

NOTE: Depending on your needs, your hearing care professional may activate a function specifically for telephone use.

Mobile phones
Your hearing aids comply with the most stringent Standards of International Electromagnetic Compatibility. Any degree of disturbance can be due to the nature of your particular mobile phone or of your wireless telephone service provider.

Using your hearing aids with iPhone, iPad and iPod touch (optional)
Your hearing aids are Made for iPhone, iPad and iPod touch, which allow for direct audio streaming and control from these devices.

Streaming from an Android™ smartphone
Some Android smartphones can stream audio directly to your hearing aids. Your device must be running Android 10 or newer and it must have the Android Streaming for Hearing Aids feature as well.

NOTE: For assistance with pairing and using these products with your hearing aids, contact your hearing care professional.

Using your hearing aid with smartphone apps (optional)
The smartphone apps send and receive signals to and from the hearing aids via smartphones.

• Do not disable app notifications.
• Install updates to keep the app working correctly.
• To obtain a printed version of the smartphone app user guide, please refer to information on the back page of this user guide or consult customer support.

NOTE:

• For assistance with pairing and using these products with your hearing aids, contact your hearing care professional or visit our support site.
• If your Bluetooth® enabled Android smartphone does not stream directly to your hearing aids, you can use our Beltone Direct Phone Link 2 for streaming capabilities.

Beltone Remote Care (optional)
If you have signed up to use Beltone Remote Care with your hearing aids, you can have your hearing aids adjusted remotely without having to visit your hearing care professional. All you need is a smart device that is Internet enabled. This allows you to experience freedom and flexibility such as:

1. Requesting remote assistance to adjust your hearing aids.
2. Ensuring the best possible performance of your hearing aids by keeping them up to date with the latest software.

NOTE: Your hearing aids will turn off during the install and update process.
For optimum performance, ensure your hearing aids are connected to the Beltone HearMax™ app and placed close to the iPhone, iPad, iPod touch or Android smartphone.

This service only works if your mobile device is connected to the internet. Your hearing care professional will provide information about this option, and how it works with the Beltone HearMax™ app.

Auto-Phone (optional)
If you place a magnet on the telephone receiver, your hearing aids will automatically switch the telephone program on when the receiver is close to your ear. When you remove the receiver from your ear, the hearing aids automatically return to the previous listening program.
NOTE: Ask your hearing care professional to enable Auto-Phone as one of your programs.

Auto-Phone warnings

• WARNING:
  • Swallowing a magnet can be harmful to your health. If a magnet is swallowed, seek immediate medical attention.
  • Keep magnets out of reach of pets, children and people with cognitive, intellectual or mental health challenges.
  • The Auto-Phone magnet may affect sensitive medical devices/electronic systems. Seek advice from the manufacturers regarding appropriate safety measures when using the Auto-Phone solution near the sensitive device/equipment (pacemakers and defibrillators) in question. If the manufacturer cannot issue a statement, we recommend keeping the magnet or a telephone equipped with the magnet 30 cm (12”) away from magnetically sensitive devices (e.g. pacemakers).

Placing the Auto-Phone magnet
Place the magnet on your telephone receiver as follows:

CAUTION:

• If you experience frequent signal loss or noise during calls, move the Auto-Phone magnet to another place on the telephone receiver.
• Only use magnets supplied by Beltone.

How to use Auto-Phone

1. Lift the telephone to your ear.
2. When you hear a short melody, the phone program is active.

NOTE:

• You may need to move the telephone receiver slightly to find the best position for a reliable Auto-Phone activation and a good hearing experience on the telephone.
• If your hearing aids have enabled the Asymmetric Phone Handling functionality, the hearing aid on the non-phone ear automatically attenuates.
• Do not cover the phone loudspeaker opening with the magnet.
• If the function does not work to your satisfaction, moving the magnet to another position may improve ease of use and comfort.
• If your hearing aids do not switch to the telephone program consistently, try repositioning the magnet or adding additional magnets.

Flight Mode (optional)
Your hearing aids can be controlled from your smartphone or Remote Control – this option can be added by your hearing care professional. However, in some areas you are requested to turn off wireless communication.
CAUTION: This hearing aid contains a radio frequency transmitter. When boarding a flight, follow airline instructions and turn off hearing aid wireless functionality when and as directed.
NOTE: You must follow the processes below for both hearing aids, even if synchronization is enabled.

Turning off wireless communication (activating Flight Mode) – Zinc-air battery models

1. Open and close the battery door on each hearing aid three times within 10 seconds.
2. 2. A 10-second double tone means the hearing aid is now in Flight Mode.

It is important to wait an additional 15 seconds after you activate Flight Mode before opening and closing the battery compartment again for any reason. If you open and close the battery compartment during this 15 second window, wireless communication will reactivate.

Activating wireless communication (turning off Flight Mode) – Zinc-air battery models

1. Open and close the battery door on each hearing aid once.
2. Wireless communication will be activated after 10 seconds.

Turning off wireless communication (activating Flight Mode) – Rechargeable model

1. Turn off your hearing aid.
2. Press the button for 9 seconds.
3. Your hearing aid will double-flash four times. If you are wearing your hearing aids at the time, you will hear double tones for about 10 seconds, meaning the hearing aid is now in Flight Mode.

Activating wireless communication (turning off Flight Mode) – Rechargeable model

1. Turn your hearing aid off and then on.
2. Wireless communication will be activated after 10 seconds.

Cleaning and caring for your hearing aids

Cleaning tools
These cleaning tools come with your hearing aids:

General instructions for care and maintenance
NOTE: To ensure you get the highest quality experience and longest useful lifetime out of your hearing aids, it is important to clean and care for them.

Keeping your hearing aids in perfect working order is easily done – just follow these steps:

1. When you remove your hearing aids, turn them off by opening the battery doors completely. This helps to dry them out. (Zinc-air battery models.)
2. After removing your hearing aids, wipe them with a soft cloth to keep them clean and dry.
3. If you use a drying agent, only use recommended products.
4. Apply cosmetics, perfume, after-shave, hairspray, lotions etc. BEFORE putting on your hearing aids. These products can damage or discolour your hearing aids.
5. Never immerse your hearing aids in liquid.
6. Keep your hearing aids away from excessive heat and direct sunlight.
7. Do not swim, shower or steam bathe while wearing your hearing aids.

CAUTION:

• Never use alcohol or other cleaning solutions to clean your hearing aids. This can damage your hearing aids and may cause a skin reaction.
• Ear wax or other residue on your hearing aids can cause an infection. To avoid this, clean your hearing aids as instructed.

Daily care and maintenance
It is important to keep your hearing aids clean and dry on a daily basis. Use the supplied cleaning tools.

NOTE:

• Never try to put the bristles of the small brush or the cleaning wire into the microphone inlets. This can damage your hearing aids.
• Do not use water to clean your receiver wires or domes
• Use a soft, dry cloth to wipe your earmoulds clean.
• Receiver wires may become stiff, brittle or discoloured over time. If you think your receiver wire needs to be replaced, contact your hearing care professional.

Changing your hearing aid domes
We recommend that your hearing care professional shows you how to change domes. You should change your domes every 3 months or more often according to the advice of your hearing care professional. Incorrect dome replacement can result in a dome being left in your ear when you remove your hearing aid.
CAUTION: If you suspect that you have a dome stuck in your ear, consult your hearing care professional.

Standard domes
The illustrations show an open dome, but the procedure is the same for all other domes. Follow these instructions to replace your domes.

Tulip domes
To change a tulip dome, follow these instructions:

Changing the wax filter
The wax filter helps keep earwax away from the components of the hearing aid. You must replace it on a regular basis. Consult your hearing care professional for advice on how often you need to do this. It will depend on how much earwax your ears produce. If you wear a dome, remove it before following this process for replacing the wax filter. You will need your box of wax filter tools.

Removing the old wax filter

Inserting the new wax filter

Storing your hearing aids — Zinc-air battery models

WARNING:

• Never put a hearing aid battery in your mouth.
• Keep hearing aid batteries away from pets, children and people with cognitive, intellectual or mental health challenges.
• Never swallow batteries nor place them inside any part of the body, as the battery can cause serious injuries. If a battery has been swallowed or placed inside any part of the body, seek immediate medical attention.

Wireless accessories

Our wireless eco-system features a comprehensive range of seamlessly integrated wireless accessories. These let you stream high quality stereo sound and speech directly to your hearing aids. Please find the list of available wireless accessories and their features below:

• Beltone Direct TV Link 2 streams audio from a TV and most other audio sources to your hearing aids at a volume that suits you.
• Remote Control adjusts volume, mutes your hearing aids and changes programs.
• Beltone Direct Remote Control 2 adjusts volume, mutes your hearing aids, changes programs and displays your settings.
• Beltone Direct Phone Link 2 streams phone conversations and stereo sound to both hearing aids and doubles as a remote control.
• Beltone Direct myPAL Micro is a microphone that can be worn by others. It improves speech comprehension in noisy situations.
• Beltone Direct myPAL Pro works like the Beltone Direct myPAL Micro but doubles as a table microphone. It connects with loop and FM systems and has a mini-jack input for streaming audio from a computer or music player.

NOTE:

• Ask your hearing care professional for more information on the range of Beltone wireless accessories.
• You should only use Beltone wireless accessories with your wireless hearing aids. For assistance with pairing your hearing aid with any of Beltone accessories, please refer to the user guide for the relevant wireless accessory.

Tinnitus Management

Tinnitus Breaker Pro module
Your Beltone hearing aid includes the Tinnitus Breaker Pro (TBP) module, a tool for generating sounds to be used in tinnitus management programs to temporarily relieve suffering from tinnitus. The TBP can generate sounds adjusted to the specific therapeutic needs and your personal preference as determined by your doctor, audiologist, or hearing care professional. Depending on the selected hearing aid program and the environment you are in, you will sometimes hear the therapeutic sound resembling a continuous or fluctuating noise.

Indications for use of the TBP module
The Tinnitus Breaker Pro module is a tool to generate sounds to be used in a Tinnitus Management Program to temporarily relieve patients suffering from Tinnitus. The target population is primarily the adult population over 18 years of age. This product may also be used with children 12 years of age or older. However, children and physically or mentally disabled users will require training by a doctor, audiologist, hearing care professional or the guardian for the insertion and removal of the hearing aid containing the TBP module.

For healthcare professionals
The Tinnitus Breaker Pro module is targeted for healthcare professionals who are treating patients suffering from Tinnitus, as well as conventional hearing disorders. The initial fitting of the Tinnitus Breaker Pro module must be done during an in-office visit by a hearing professional participating in a Tinnitus Management Program. If deemed feasible by the hearing professional, subsequent fittings of the Tinnitus Breaker Pro module may be performed remotely and in real time while having live communication via live audio, video and chat on the user’s dedicated app.

User instructions for the TBP module

• Description of the device
  • The Tinnitus Breaker Pro (TBP) Module is a software tool that generates sounds to be used in tinnitus management programs to temporarily relieve suffering from tinnitus.
• Explanation of how the device functions
  • The TBP module is a frequency and amplitude shaped white-noise generator. The noise signal level and frequency characteristics can be adjusted to the specific therapeutic needs as determined by your doctor, audiologist or hearing care professional.
  • Your doctor, audiologist or hearing care professional can modulate the generated noise with the purpose of making it more pleasant. The noise can then resemble, for example, breaking waves on a shore.
  • Modulation level and speed can also be configured to your likes and needs. An additional feature can be enabled by your hearing care professional that allows you to select predefined sounds that simulate sounds from nature, such as breaking waves or running water.
  • If you have two wireless hearing aids that support ear-to-ear synchronisation, this functionality can be enabled by your hearing care professional. This will cause the Tinnitus Breaker Pro to synchronise the sound in both hearing aids.
  • If your tinnitus troubles you only in quiet environments, your doctor, audiologist or hearing care professional can set the TBP Module so that it becomes audible exclusively in such surroundings. The overall sound level can be adjusted via an optional volume control. Your doctor, audiologist or hearing care professional will review with you the need for having such a control.
  • For hearing aids where ear-to-ear synchronisation is enabled, your hearing care professional can also enable environmental monitoring synchronisation so that the TBP noise level is automatically adjusted simultaneously in both hearing aids dependent on the background sound level. Additionally, since the hearing aid has a volume control, the background noise level monitored by the hearing aid and the volume control can be used simultaneously to adjust the generated noise level in both hearing aids.
• The scientific concepts that form the basis for the device
  • The TBP module provides sound enrichment with the aim of surrounding the tinnitus sound with a neutral sound which is easily ignored. Sound enrichment is an important component of most approaches to tinnitus management, such as Tinnitus Retraining Therapy (TRT).
  • To assist habituation to tinnitus, this needs to be audible. The ideal level of the TBP module, therefore, should be set so that it starts to blend with the tinnitus, and so that you can hear both your tinnitus as well as the sound used.
  • In a majority of instances, the TBP module can also be set to mask the tinnitus sound, so to provide temporary relief by introducing a more pleasant and controllable sound source.
• TBP volume control
  • The sound generator is set to a specific loudness level by the hearing care professional. When switching the sound generator on, the volume will have this optimal setting. Therefore, it might not be necessary to control the volume (loudness) manually.
  • However, the volume control provides the ability to adjust the volume, or amount of stimulus, to the liking of the user. The tinnitus sound generator volume can only be adjusted within the range set by the hearing care professional. The volume control is an optional feature in the TBP module used for adjusting the sound generator output level.
  • Using TBP with smartphone apps
    The tinnitus sound generator control via hearing aid push buttons can be enhanced with wireless control from a TBP control app on a smartphone or mobile device. This functionality is available in supported hearing aids when a hearing care professional has enabled the TBP functionality during fitting of the hearing aid.
    NOTE: To use smartphone apps, the hearing aid must be connected with the smartphone or mobile device.

TBP – Technical specifications

Audio signal technology: Digital.
Available sounds
White noise signal which can be shaped with the following configurations:

The white noise signal can be modulated in amplitude with an attenuation depth of up to 14 dB.

Prescription use of this device
The TBP module should be used as prescribed by your doctor, audiologist or hearing healthcare professional. In order to avoid permanent hearing damage, the maximum daily usage depends on the level of the generated sound. To adjust TBP, please consult your hearing healthcare professional. Should you develop any side effects from using the sound generator, such as dizziness, nausea, headaches, perceived decrease in auditory function or increase in tinnitus perception, you should discontinue use of the sound generator and seek medical evaluation.

Target population
The target population is primarily the adult population over 18 years of age. This product may also be used with children 12 years of age or older. However, children and physically or mentally disabled users will require training by a doctor, audiologist, hearing care professional or the guardian for the insertion and removal of the hearing aid containing the TBP module.

Important notice for prospective sound generator users

• A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask internal noises. It is also used as an aid in hearing external noises and speech.
• Good health practice requires that a person with a tinnitus condition have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before using a sound generator. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists or otorhinolaryngologists.
• The purpose of medical evaluation is to assure that all medically treatable conditions that may affect tinnitus are identified and treated before the sound generator instrument is used.
• The sound generator instrument is a tool to generate sounds to be used with appropriate counselling and/or in a tinnitus management program to relieve patients suffering from tinnitus.

Warning information

• WARNING:
  • Sound generators can be dangerous if improperly used.
  • Sound generators should be used only as advised by your doctor, audiologist, or hearing care professional.
  • Sound generators are not toys and should be kept out of reach of anyone who might cause themselves injury (especially children and pets).
• CAUTION:
  • Should the user develop any side effects from using the sound generator, such as dizziness, nausea, headaches, perceived decrease in auditory function or increase in tinnitus perception, the user should discontinue use of the sound generator and seek medical evaluation.
  • To prevent unintended usage by paediatric or physically or mentally disabled users, the volume control must, if enabled, be configured to only provide a decrease of the sound generator output level.
  • Children and physically or mentally disabled users will require guardian supervision while wearing the TBP hearing aid.

Tinnitus Breaker Pro warning to hearing care professionals
A hearing care professional should advise a prospective sound generator user to consult promptly with a licensed physician (preferably an ear specialist) before getting a sound generator, if the hearing care professional determines through inquiry, actual observation, or review of any other available information concerning the prospective user that the prospective user has any of the following conditions:

1. Visible congenital or traumatic deformity of the ear.
2. History of active drainage from the ear within the previous 90 days.
3. History of sudden or rapidly progressive hearing loss within the previous 90 days.
4. Acute or chronic dizziness.
5. Unilateral hearing loss of sudden or recent onset within the previous 90 days.
6. Audiometric air-bone gap equal to or greater than 15 dB at 500 Hertz (Hz), 1000 Hz, and 2000 Hz.
7. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
8. Pain or discomfort in the ear.

CAUTION: The maximum output of the sound generator falls into the range that can cause hearing loss according to OSHA regulations. In accordance with NIOSH recommendations, the user should not use the sound generator for more than eight (8) hours a day when this is set to a level of 85 dB SPL or above. When the sound generator is set to levels of 90 dB SPL or above the user should not use the sound generator for more than two (2) hours per day. In no case should the sound generator be worn at uncomfortable levels.

General warnings and cautions

WARNING:

• Consult a hearing care professional:
  • If you think there may be a foreign object in your ear canal
  • If you experience skin irritation
  • If excessive ear wax accumulates with the use of the hearing aid
• Do not wear your hearing aids while being exposed to radiation. Some types of radiation, e.g. from MRI or CT scanners, can affect the settings in your hearing aids, causing malfunction and potentially damage to your hearing.
• Other types of radiation, such as burglar alarms, room surveillance systems, mobile phones and radio equipment will not damage your hearing aids. They may, however, briefly affect the sound quality in your hearing aids and may create undesired sounds.
• Never use your hearing aids in places with explosive gases such as mines, oil fields or similar unless these areas are certified for hearing aid use. Using your hearing aids in places that are not certified for hearing aid use can be dangerous.
• For safety reasons, use only the charger supplied by Beltone. (Rechargeable model).
• Do not attempt to dry your hearing aids in an oven, microwave oven or other heating equipment. This will cause them to melt and may cause burns to your skin.
• External devices connected to the electrical input must be safe according to the requirements of IEC 60601-1, IEC 60065, EN/IEC 62368-1, or IEC 60950-1, as appropriate (wired connection, for example HI-PRO, SpeedLink).

Warnings related to power hearing aids

• A power hearing aid can produce very loud sound to compensate for a severe or profound hearing loss. There is therefore a risk of further impairing the remaining hearing.
• Your hearing aids have been customised to amplify soft and loud sounds according to your particular needs. If the amplification seems too loud or you suspect the hearing aid is malfunctioning (e.g. you hear distorted or unusual sound), contact your hearing care professional. A malfunctioning hearing aid can damage your hearing.
• In general, exposure to loud sounds can damage your hearing. This could be loud music or loud environments. You can best protect your hearing by reducing exposure to loud sound and environments or by using hearing protection.
• Warning to hearing care professionals: Special care should be exercised in selecting and fitting hearing aids with a maximum sound pressure level that exceeds 132 dB SPL, measured in a 2 cc acoustic coupler in accordance with IEC 60318-5:2006. The remaining hearing may risk further impairment.

CAUTION:

• Use your hearing aids as your hearing care professional recommends. Incorrect use may damage your hearing.
• Do not use a broken hearing aid. It may not work properly and may be harmful to your hearing. It may also cause scratches or sores due to sharp edges.
• Use only original consumables from Beltone, e.g. domes.
• Use only accessories intended for use with your hearing aids. Consult your hearing aid professional for more information.
• Do not try to modify the shape of your hearing aid or accessories. This can cause skin reactions or sharp edges leading to scratches or sores.
• If you have two hearing aids, they may be programmed differently. Do not swap them as this could damage your hearing. Your hearing aids are colour-coded. Left = blue. Right = red. If your hearing aids are not colour coded, ask your hearing care professional to add colour coding.
• If you experience side effects, contact your hearing care professional. Possible side effects from wearing a hearing aid may be:
  • Dizziness
  • Tinnitus
  • Perceived worsening of hearing loss
  • Nausea
  • Headache
  • Skin reaction
  • Ear wax accumulation
• If you suspect that you have a dome, wax filter or other object in your ear canal, consult your hearing care professional. These objects can be harmful and can cause an infection in your ear.
• If you have a sore or injury where your hearing aid touches your ear or head, continued use of the hearing aid may cause it to worsen or prevent it from healing. Consult your hearing care professional for assistance.
• Your hearing aids are tuned to your hearing. Do not allow others to use your hearing aids as this can damage their hearing.
• When using wireless functions, your hearing aid uses low-powered digitally coded transmissions to communicate with other wireless devices. It is possible, but not likely, that other electronic devices will be affected. If this happens, move the hearing aid away from the affected electronic device.
• Turn off hearing aid wireless functionality when this is required.
• For Hearing Care Professionals: Do not change the outer casing or any parts of a hearing aid unless appropriately protected against ESD.

Troubleshooting

care professional.
Are you holding an object (e.g. a hat or a telephone mouthpiece) close to the hearing aid?| Move your hand away to create more space between the hearing aid and the object.
Is your ear full of wax?| Visit your physician.
Issue| Potential cause| Potential solution
---|---|---
No sound| Is the hearing aid turned on?| Turn it on.
Is there a battery in the hearing aid? (Zinc-air battery models)| Insert a new battery.
Is the battery still good? (Zinc-air battery models)| Replace with a new battery.
Is the hearing aid charged? (Rechargeable model)| Charge the hearing aid.

(See the user manual for your charger.)

Is the hearing aid charger charged? (Rechargeable model)| Charge the hearing aid charger.

(See the user guide for your charger.)

Is the receiver wire broken or the earmould clogged?| Consult your hearing care professional.
Is your ear full of wax?| Visit your physician.
Issue| Potential cause| Potential solution
---|---|---
Sound is distorted, spluttering or weak?| Is the battery dead? (Zinc-air battery models)| Replace with a new battery.
Is the battery dirty? (Zinc-air battery models)| Clean it or replace it with a new one.
Is the receiver wire broken or the earmould clogged?| Consult your hearing care professional.
Is there moisture in your hearing aid?| Use a desiccant (drying kit).
Battery drains very quickly.| Did you leave your hearing aid switched on for long periods of time?| Always turn off your hearing aids when you are not using them, e.g. during the night.
Is the battery old?

(Zinc-air battery models)

| Check the battery packaging.
Is the hearing aid 3-4 years old? (Rechargeable model)| Visit your hearing care professional.
Hearing aid is not charging| Is the hearing aid sitting correctly in the charger?| Reinsert the hearing aid in the charger. (See the user guide for your charger.)
Is the hearing aid charger charged or plugged into a power source?| Charge the hearing aid charger. (See the user guide for your charger.)

Warnings to hearing care professionals (US only)

Hearing aid expectations

• A hearing aid will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions.
• Consistent use of the hearing aid is recommended. In most cases, infrequent use does not permit you to get full benefit from it.
• The use of a hearing aid is only part of hearing rehabilitation and may need to be supplemented by auditory training and instructions in lip-reading.

Warning to Hearing Aid Dispensers
A hearing aid dispenser should advise a prospective hearing aid user to consult promptly with a licensed physician (preferably an ear specialist) before dispensing a hearing aid, if the hearing aid dispenser determines through inquiry, actual observation, or review of any other available information concerning the prospective user, that the prospective user has any of the following conditions:

1. Visible congenital or traumatic deformity of the ear.
2. History of active drainage from the ear within the previous 90 days.
3. History of sudden or rapidly progressive hearing loss within the previous 90 days.
4. Acute or chronic dizziness.
5. Unilateral hearing loss of sudden or recent onset within the previous 90 days.
6. Audiometric air-bone gap equal to or greater than 15 dB at 500 Hertz (Hz), 1000 Hz, and 2000 Hz.
7. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
8. Pain or discomfort in the ear.

Important notice for prospective hearing aid users
Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists or otorhinolaryngologists. The purpose of medical evaluation is to assure that all medically treatable conditions that may affect hearing are identified and treated before the hearing aid is purchased.
Following the medical evaluation, the physician will give you a written statement that states that your hearing loss has been medically evaluated and that you may be considered a candidate for a hearing aid. The physician will refer you to an audiologist or a hearing aid dispenser, as appropriate, for a hearing aid evaluation. The audiologist or hearing aid dispenser will conduct a hearing aid evaluation to assess your ability to hear with and without a hearing aid. The hearing aid evaluation will enable the audiologist or hearing aid dispenser to select and fit a hearing aid to your individual needs. If you have reservations about your ability to adapt to amplification, you should inquire about the availability of a trial-rental or purchase-option program. Many hearing aid dispensers now offer programs that permit you to wear a hearing aid for a period of time for a nominal fee after which you may decide if you want to purchase the hearing aid. Federal law restricts the sale of hearing aids to those individuals who have obtained a medical evaluation from a licensed physician. Federal law permits a fully informed adult to sign a waiver statement declining the medical evaluation for religious or personal beliefs that preclude consultation with a physician. The exercise of such a waiver is not in your best health interest and its use is strongly discouraged.

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

Regulatory information

Warranties and repairs
The manufacturer provides a warranty on hearing aids in the event of defects in workmanship or materials, as described in applicable warranty documentation. In its service policy, the manufacturer pledges to secure functionality at least equivalent to the original hearing aid. As a signatory to the United Nations Global Compact initiative, the manufacturer is committed to doing this in line with environment-friendly best practices. Hearing aids therefore, at the manufacturer’s discretion, may be replaced by new products or products manufactured from new or serviceable used parts, or repaired using new or refurbished replacement parts. The warranty period of hearing aids is designated on your warranty card, which is provided by your hearing care professional. For hearing aids that require service, please contact your hearing care professional for assistance. Hearing aids that malfunction must be repaired by a qualified technician. Do not attempt to open the case of hearing aids, as this will invalidate the warranty.

Temperature test, transport and storage information
Our hearing aids are subjected to various tests in temperature and damp heating cycling between -25 °C (-13 °F) and +70 °C (+158 °F) according to internal and industry standards. During normal operation the temperature should not exceed the limit values of +5 °C (+41 °F) to +40 °C (104 °F) at a relative humidity of 90%, non-condensing. An atmospheric pressure between 700 hPa and 1060 hPa is appropriate.

During transport or storage, the temperature should not exceed the limit values of:

• -25 °C (-13°F) to +5 °C (41°F)
• +5 °C (41 °F) to +35 °C (95 °F) at a relative humidity up to 90 %, non-condensing

• +35 °C (95 °F) to +70 °C (158 °F) at a water vapour pressure up to 50 hPa.

• Warm-up time: 5 minutes.
• Cool-down time: 5 minutes.

Expected service lifetime
The expected service lifetime for the hearing aid is minimum 5 years.

Statement
This device complies with part 15 of the FCC rules and ISED rules. 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.

NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules and ISED rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna
• Increase the separation between the equipment and the receiver
• Connect the equipment to an outlet or a circuit different from the one to which the receiver is connected
• Consult the dealer or an experienced radio/TV technician for help.

Changes or modifications can void the user’s authority to operate the equipment.

The products are in compliance with the following regulatory requirements:

• In EU: The device conforms to the Essential Requirements according to Annex I of Council Directive 93/42/EEC for medical devices (MDD).
• Hereby, Beltone A/S declares that the radio equipment types CAR46A, CAR12A and CAR13A are in compliance with Directive 2014/53/EU.
• The full text of the EU declaration of conformity is available at the following internet address: www.beltone.com/declarations.
• In the US: FCC CFR 47 Part 15, subpart C.
• Other identified applicable international regulatory requirements in countries outside the EU and US. Please refer to local country requirements for these areas.
• In Canada: these hearing aids are certified under the rules of ISED.
• Japanese Radio Law and Japanese Telecommunications Business Law Compliance. This device is granted pursuant to the Japanese Radio Law (電波法) and the Japanese telecommunications Business Law (電気通信事業法). This device should not be modified (otherwise the granted designation number will become invalid).

Type designations
Hearing aid type designations for models included in this user guide are:

• CAR46A, FCC ID: X26CAR46A, IC: 6941C-CAR46A
• CAR12A, FCC ID: X26CAR12A, IC: 6941C-CAR12A
• CAR13A, FCC ID: X26CAR13A, IC: 6941C-CAR13A.

This device transmits and receives RF signals in the frequency range of 2.4 GHz – 2.48 GHz.

Hearing aid variants

• Mini Receiver In-the-Ear (RIE) hearing aids of type CAR46A with FCC ID X26CAR46A, IC number 6941C-CAR46A and rechargeable Li-Ion battery are available in the following variants:
  IMG1763-DRWC, IMG963-DRWC, IMG663-DRWC, IMG463-DRWC. Nominal RF output power transmitted is -11.5 dBm.

• Mini Receiver In-the-Ear (RIE) hearing aids of type CAR12A with FCC ID X26CAR12A, IC number 6941C-CAR12A and size 312 Zinc-air battery are available in the following variants:
  IMG1763-DRW, IMG963-DRW, IMG663-DRW, IMG463-DRW. Nominal RF output power transmitted is -10.34 dBm.

• Receiver-in-the-ear (RIE) hearing aids of type CAR13A with FCC ID X26CAR13A, IC number 6941C-CAR13A and size 13 Zinc-air battery are available in the following variants:
  IMG1764-DRW, IMG964-DRW, IMG664-DRW, IMG464-DRW. Nominal RF output power transmitted is -7.1 dBm.
  All the above-mentioned hearing aids contain a magnetic induction radio operating at the 10.66 MHz frequency. The magnetic field strength of the radio is: Max. -24 dBµA/m at a 10 m distance.

Symbols

Technical specifications

RIE — LP/MP receiver
Models: IMG1763-DRWC, IMG1763-DRW, IMG1764-DRW, IMG963-DRWC, IMG963-DRW, IMG964-DRW, IMG663-DRWC, IMG663-DRW, IMG664-DRW, IMG463-DRWC, IMG463-DRW, IMG464-DRW

Measured according to ANSI S3.22-2014, IEC 60118-0:2015, JIS C 5512: 2015, 2cc coupler.

• Telecoil is only for these models: IMG1764-DRW, IMG964-DRW, IMG664-DRW, IMG464-DRW.
• Expected operating time of the rechargeable battery depends on active features, the use of wireless accessories, hearing loss, battery age and sound environment.

RIE — HP/UP receiver
Models: IMG1763-DRWC, IMG1763-DRW, IMG1764-DRW, IMG963-DRWC, IMG963-DRW, IMG964-DRW, IMG663-DRWC, IMG663-DRW, IMG664-DRW, IMG463-DRWC, IMG463-DRW, IMG464-DRW

Measured according to ANSI S3.22-2014, IEC 60118-0:2015, JIS C 5512: 2015, 2cc coupler.

• Telecoil is only for these models: IMG1764-DRW, IMG964-DRW, IMG664-DRW, IMG464-DRW.
• Expected operating time of the rechargeable battery depends on active features, the use of wireless accessories, hearing loss, battery age and sound environment.

RIE — MM receiver
Models: IMG1763-DRWC, IMG1763-DRW, IMG1764-DRW, IMG963-DRWC, IMG963-DRW, IMG964-DRW, IMG663-DRWC, IMG663-DRW, IMG664-DRW.

Measured according to ANSI S3.22-2014, IEC 60118-0:2015, JIS C 5512: 2015, 2cc coupler.

• Telecoil is only for these models: IMG1764-DRW, IMG964-DRW, IMG664-DRW, IMG464-DRW.
• Expected operating time of the rechargeable battery depends on active features, the use of wireless accessories, hearing loss, battery age and sound environment.

Additional information

Acknowledgments
Portions of this software are written by Kenneth MacKay (micro-ecc) and licensed under the following terms and conditions: Copyright ® 2014, Kenneth MacKay. All rights reserved. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:

THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS “AS IS” AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE COPYRIGHT HOLDER OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.

NOTE: Use of the Made for Apple badge means that an accessory has been designed to connect specifically to iPhone, iPad and iPod touch models, 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.

© 2022 GN Hearing Care Corporation. All rights reserved. Beltone is a trademark of GN Hearing Care Corporation. 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., registered in the US and other countries. Android, Google Play and the Google Play logo are trademarks of Google LLC. The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc.

Manufacturer according to EU Medical Device Directive 93/42/EEC:

Beltone A/S
Lautrupbjerg 7
DK-2750 Ballerup
Denmark

United Kingdom
GN Hearing UK Ltd
Unit 13 Talisman Business Centre
Bicester OX26 6HR
United Kingdom
Tel.: +44 1869 352 800
beltone.com

Australia
GN Hearing Australia Pty Ltd
Gate C, 19-25 Khartoum Rd
Macquarie Technology Park
Macquarie Park NSW 2113
Australia
Tel.: (free) 1800 658 955
beltone.com

New Zealand
GN Hearing New Zealand Limited
Ground Floor, North Entrance
4 Fred Thomas Drive
Takapuna, Auckland, 0622
Tel.: (free) 0800 900 126
beltone.com

Singapore
GN Hearing Pte. Ltd
456 Alexandra Road

22-01

Singapore 119962
Tel: +65 6320 9388
beltone.com

Any serious incident that has occurred in relation to the device should be reported to the Legal manufacturer Beltone A/S and the competent authority of the EU Member State in which the user and/or patient is established.

References

• Hearing Aids Near Me - Free Hearing Test Online | Beltone
• Declarations of conformity | Beltone

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