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User guide
Custom hearing aids resound.com
Hearing aid information
Left hearing aid
Serial number
Model number
Battery type £ CIC size 10A
£ ITE size 13 o ITC, ITE size 312
£ MIH size 13 £ MIH size 312
Serial number
Model number
Right hearing aid
2
3
Program
1
4
Beep
One beep
Two beeps
Three beeps
Four beeps
Description
2
Table of Contents
How to get your hearing aid ready for use
How to place the hearing aids in your ears
How to remove the hearing aids from your ears
How to clean and maintain your hearing aids
3
Warnings to hearing care professionals (US only)
4
Introduction
Thank you for choosing our hearing aids. We recommend that you use your hearing aids every day that way you will fully benefit from them.
NOTE: Read this booklet carefully before you start 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.
This hearing device is intended for use by users over 12 years of age.
For devices including a Tinnitus Sound Generator module:
The Tinnitus Sound Generator 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.
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Your hearing aid
Your hearing aid – Completely-In-the-Canal (CIC)
1. Push button (optional)
2. Battery door and On/Off switch
3. Removal cord (optional)
4. Sound outlet
10
7
5. Wax filter
6. Vent
7. Microphone sound inlet(s)
8. Manufacturer
9. Serial number
10. Antenna
10
3
2
Manufacturer
XXXX
9
4
5
1
3
6
8
6
Your hearing aid – In-The-Canal (ITC)/In-The-Ear (ITE)
1. Microphone sound inlets
2. Push button (optional)
3. Battery door
4. Volume control (optional)
5. Vent
3
1
2
1
4
5
7
Your hearing aid – MIH (Microphone-In-Helix)
1. Push button (optional)
2. Battery compartment /On-Off switch
3. Removal cord (optional)
4. Sound outlet
5. Wax filter
6. Vent
7. Microphone sound inlet
8. Microphone in helix tubing
9. Volume control (optional)
10. Serial number
11. Manufacturer
8
2
2
6
4
9
1
3
8
4
5
7
8
8
3
Manufacturer
XXXX
10
11
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How to get your hearing aid ready for use
Replacing the battery
1. Open the battery door completely by using your fingernail. Remove the used battery if present.
2. Prepare the new battery. Remove the protective foil to activate the battery. Wait for 2 minutes before inserting the battery into the hearing aid.
3. Insert the new battery with the positive side in the correct position.
Always insert the battery in the door: never directly into the hearing aid. Gently close the battery door.
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NOTE: Always use new Zinc-Air batteries that have a minimum remaining shelf life of one year.
At night, switch off the hearing aid and open the battery door completely to allow moisture to evaporate and prolong the hearing aid’s lifespan.
If the hearing aid is experiencing frequent loss of connection to wireless accessories, contact your hearing care professional for a list of low impedance batteries.
Keep spare batteries on hand.
Battery warnings
WARNING: Batteries contain dangerous substances and should be disposed of carefully in the interest of your safety and for the environment. Please note:
1.
Keep batteries away from pets, children and mentally challenged persons.
2.
DO NOT place batteries in your mouth. Consult a physician immediately if a battery has been swallowed, as they can be harmful to your health.
3.
Do not attempt to recharge batteries (Zinc-Air) which are not specifically designated as rechargeable because they may leak or explode.
4.
DO NOT attempt to dispose of batteries by burning them.
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5.
Used batteries are harmful to the environment. Please dispose of them according to local regulations or return them to your hearing care professional.
6.
To save battery power, turn your hearing aids off when they are not in use.
WARNING: Batteries may leak. Remove the battery if you leave the hearing aids unused for longer periods.
WARNING: If the batteries are not inserted correctly, the device will not work and the batteries may build up heat. If this happens, please remove the batteries.
NOTE: Always use new Zinc-Air batteries that have a minimum remaining shelf life of one year.
Low battery warning
When the batteries are low on power, your hearing aids reduce the volume, and play a melody every 15 minutes until they are completely drained and turn off.
Low battery indicator when paired with wireless accessories (optional)
The batteries drain faster when you use wireless functionalities like direct streaming from your smartphone or streaming sound from your TV with our TV Streamer. When the batteries deplete, the support of some wireless accessories shuts down. Full functionality returns when you insert a
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new battery. The table below shows how the functionality decreases with the depletion of the batteries.
Battery level
Fully charged
Low
Depleted (change battery)
Signal Hearing aid
P
P
P
Remote control Streaming
P P
P x x x
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How to place the hearing aids in your ears
How to tell right from left
If you have two hearing aids, it is important that you can recognize one from the other.
Your right hearing aid will always have a red marking or shell, while your left hearing aid will have a blue marking or shell.
Insert hearing aids
Insert Completely-In-The-Canal and In-The-Ear (ITE)
1. Hold the hearing aid between your thumb and index finger, either above and below or on the sides.
2. Place the sound outlet portion into your ear canal. Turn the top part of the hearing aid gently backwards and forwards so that it tucks behind the fold of skin above your ear canal.
3. Insert the hearing aid into your ear canal. Opening and closing your mouth may ease insertion.
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By experimenting, you may discover an easier method. With proper insertion, hearing aids should fit snugly but comfortably.
NOTE: It may be helpful to pull your ear up and outward with your opposite hand during insertion.
Insert Mic-In-Helix
1. Hold the hearing aid between your thumb and index finger.
2. Place the sound outlet portion into your ear canal.
3. Gently twist and push the hearing aid into your ear. Opening and closing your mouth can ease insertion.
4. Gently push the microphone into the creased area of the ear, and make sure the tubing is in place.
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How to remove the hearing aids from your ears
Remove Mic-In-Helix and Completely-In-Canal
1. Hold the removal cord with your thumb and index finger and pull outward.
2. Hold the edges of the hearing aid with your thumb and forefinger and pull outward while slightly rotating your hand forward.
Remove In-The-Canal and In-The-Ear (ITE)
1. Hold the edges of the hearing aid with your thumb and forefinger.
2. Pull outward while slightly rotating your hand forward.
CAUTION: Never attempt to modify the shape of the hearing aid or tubing yourself.
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How to use your hearing aids
Operation of the hearing aid
The volume control (if present) allows you to adjust the volume of your hearing aids to your liking.
1. To increase the volume, turn the volume control up (+).
2. To decrease the volume, turn the volume control down (-).
When you change the volume, the hearing aid responds with a beep. When you reach the upper or lower limits, the hearing aid responds with a low-pitched beep.
NOTE: If you have two hearing aids with the Synchronized Volume Control function enabled, volume control adjustments to one hearing aid automatically repeats in the second hearing aid. When you change volume on one of the hearing aids, it responds with one or more beeps. A beep in the second hearing aid follows.
If your hearing aids support wireless Remote Control, you may use the supported Remote
Control or the smartphone app to adjust e.g. the volume.
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Push button (optional)
Your hearing aid has a push button allowing you to use up to four different listening programs. The list on page 2 tells which programs have been enabled.
1.
Tap the program button to switch between programs.
2.
You will then hear one or more beeps. The number of beeps indicates which program you have selected (one beep = program one, two beeps = program two, etc.).
3.
When you turn the hearing aids off and then back on, they always return to the default setting
(program one and preset volume).
NOTE: If you have two hearing aids with the Synchronized Push Button enabled, program changes to one hearing aid automatically repeats in the second hearing aid. The same number of confirmation beeps will follow in the second hearing aid. This Synchronized Push
Button can also be configured to allow one side to control volume increase and the other to control volume decrease. The volume changes to one hearing aid are repeated on the other side to keep levels the same.
Telecoil
(Optional for ITC-DWT, ITE-DWT, MIH-WT models only)
Your hearing aid may have a telecoil. The Telecoil program may help to improve speech understanding with Hearing Aid Compatible (HAC) telephones and in theaters, cinemas, houses of
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worship, etc. that have a hearing loop installed.
When you select the Telecoil program, your hearing aid picks up signals from the hearing loop or
HAC telephone. Your hearing care professional can activate the Telecoil program.
NOTE: The telecoil cannot work without a hearing loop (aka induction-loop) or a HAC telephone.
NOTE: If you are having trouble hearing with the hearing loop, ask you hearing care professional to adjust the program.
NOTE: If there is no sound from the hearing aids in a hearing loop system and an active
Telecoil program, the hearing loop system may not be turned on or is not operating correctly.
NOTE: The sound from the hearing loop and the hearing aids' microphones can be mixed to your preference. Ask your hearing care professional if this could be useful for you.
Hearing loop systems
To use tele loop systems, follow these steps:
1.
Switch your hearing aid to the telecoil program.
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2.
Find a good spot. Reception is not clear in all locations, it depends on the induction loop. Look for signs or find another spot.
3.
If needed, adjust the volume.
4.
When you leave, switch to Program 1.
How to use the telecoil program
To use your telecoil program with hearing loop systems, follow these steps:
1.
Switch your hearing aids to the telecoil program.
2.
Find a good spot. Reception is not clear in all locations, as it depends on the hearing loop. Look for signals or find another spot.
3.
If needed, adjust the volume.
4.
When you leave, switch to your preferred program.
HAC telephone
Some smartphones are hearing aid compatible (HAC). The HAC phone establishes a small hearing loop that your hearing aids can connect to. The telecoil picks up the HAC phone's signal and converts it to sound.
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To use a HAC phone, follow these steps:
1.
Switch your hearing aid to the Telecoil program.
2.
Pick up the phone and make a call or answer a call.
3.
Hold the phone close to the hearing aid and tilt it slightly outwards.
4.
Listen to the dial tone and move the telephone to get the best reception.
5.
If needed, adjust the volume.
6.
When you hang up, switch to your preferred program.
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NOTE: If the phone has a poor telecoil signal, use the microphone program. To avoid whistling, do not hold the handset too tightly against your ear.
NOTE: Ask your hearing care professional to enable the Telecoil program in your hearing aids.
NOTE: If you see a “M3”, “M4”, “T3”, or “T4” on the box, then the smartphone is HAC compliant. If you find it difficult to obtain a good result while using your smartphone, your hearing care professional will be able to give you advice on available wireless accessories to enhance listening capabilities. Ask your hearing care professional for advice regarding HAC smartphones.
Telephone use
Your hearing aid allows you to use your telephone as you normally do.
Finding the optimal position for holding a telephone may require practice.
The following suggestions may be helpful:
1.
Depending on your fitting and hearing status, either hold the telephone up to your ear canal or hold it close to the hearing aid microphones as illustrated.
2.
If whistling occurs, try holding the telephone in the same position for a few seconds as the hearing aid may be able to cancel the whistling.
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3.
Holding the telephone slightly away from the ear can also stop any whistling.
NOTE: Depending on your individual needs, your hearing care professional may activate a program specifically for telephone use.
How to use 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 on Android 10 or newer and it needs to 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.
Mobile phones
Your hearing aid complies 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.
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NOTE: If you find it difficult to obtain a good result while using your mobile phone, your hearing care professional will be able to give you advice on available wireless accessories to enhance listening capabilities.
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Advanced options
Phone Now (optional)
By placing a magnet on the telephone receiver, your hearing aids 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 Phone Now as one of your programs.
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Place the Phone Now magnet
Place the magnet on your telephone receiver to allow operation of the Phone Now function. In order to place the magnet properly:
1. Clean the telephone thoroughly
2. Remove foil from magnet 3. Place the magnet
NOTE: If you are not satisfied with the strength of Phone Now, you can reposition the magnet or add additional magnets.
Prior to placing the magnet on the telephone or cell phone, use a recommended cleaning agent to clean the telephone.
How to use Phone Now
1.
Lift the telephone to your ear.
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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 reliable Phone Now activation and a good hearing experience on the telephone.
If your hearing aids have enabled the Comfort Phone functionality, the hearing aid on the non-phone ear automatically turns down the volume.
Ask your hearing care professional to enable Phone Now as one of your programs.
Do not cover the loudspeaker opening with the magnet.
If the program does not work to your satisfaction, moving the magnet to another position may improve ease of use and comfort while speaking.
If the hearing aids do not switch to the telephone program every time, you can reposition the magnet or add additional magnets.
Use a recommended cleaning agent.
Phone Now warnings
1.
If a magnet is swallowed, seek immediate assistance from a medical practitioner.
2.
Keep magnets out of reach of pets, children and people with mental disabilities. If a magnet is swallowed, please seek advice from a medical practitioner.
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3.
The magnet may affect some medical devices or electronic systems. The manufacturer of any magnetically sensitive devices (e.g., pacemakers) should advise you regarding appropriate safety precautions when using your hearing aid and magnet in close proximity to the medical device or electronic system 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).
Phone Now precautions
• If you experience frequent signal loss or noise during calls, move the magnet to another place on the telephone receiver.
• Only use original magnets supplied by the manufacturer.
Flight Mode (optional)
Your hearing aid allows you to control it from your smartphone or remote control. However, in some areas you are requested to turn off wireless communication.
When boarding a flight or entering an area where RF transmitters are prohibited, wireless functionality must be deactivated.
Follow these steps to turn off wireless mode:
1.
For each hearing aid, open and close (open-close, open-close, open-close) the battery door three times within a 10-second period.
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2.
Double-dings for ten seconds ( etc.) indicate that your hearing aid is in Flight mode.
Follow these steps to activate wireless mode:
1.
For each hearing aid, open and close the battery door once.
2.
Your hearing aids are in wireless mode after 10 seconds.
NOTE: Both hearing aids must be set in Flight mode - even with synchronization enabled.
It is important to wait an additional 15 seconds after wireless function resumes before opening and closing the battery compartment again for any reason. Flight mode will resume if you open and close the battery compartment during this 15 second window.
Using your hearing aid with smartphone apps (optional)
Our smartphone apps are intended to be used with our wireless hearing aids. The smartphone apps send and receive signals from the hearing aids via smartphones.
• Do not disable app notifications.
• Install updates to keep the app working correctly.
• Only use the app with hearing aids from the same manufacturer. We take no responsibility if the app is used with other hearing aids.
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• If you want a printed version of the smartphone app user guide, please go to our website or consult customer support.
NOTE: For assistance with pairing and using these products with your hearing aids, please contact your hearing care professional or visit our support site.
NOTE: If your Bluetooth® enabled Android smartphone does not stream directly to your hearing aids, you are able to answer the telephone if you use ReSound Phone Clip+.
ReSound Assist (optional)
If you have signed up to use ReSound Assist available with your hearing aids, you can allow your hearing aids to be adjusted remotely without having to go to your hearing care professional. All you need is an internet-enabled smart device. This allows you to experience unprecedented freedom and flexibility by:
1.
requesting assistance remotely to adjust your hearing aids to be a better fit for you;
2.
keeping your hearing aids up to date with the latest software to ensure the best performance possible.
NOTE: Your hearing aids shut down during the install and update process.
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For optimum performance, make sure the hearing aids are connected to the ReSound Smart 3D™ app and placed close to the iPhone, iPad, iPod touch or the Android smartphone before applying the changes.
This service only works if your smart device is connected to the internet. Your hearing care professional will provide information regarding this option, and how it works with the ReSound
Smart 3D™ app.
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How to clean and maintain your hearing aids
Daily maintenance
NOTE: It is important to keep your hearing aid clean and dry. On a daily basis, clean the hearing aids using a soft cloth or tissue. In order to avoid damage due to humidity or excessive perspiration, the use of a drying kit is recommended.
NOTE: Do not use alcohol or any other solvents to clean your hearing aids - the protective coating will be damaged.
How to replace wax filters
Custom hearing aids may have wax filters that protect against wax and moisture. It is recommended that these be changed as needed.
Change HF3 wax filters
1.
Brush the sound outlet area with the sound outlet pointed down.
2.
Insert the threaded end of the wax filter tool into the used wax filter, and gently rotate clockwise.
3.
Gently pull until the used filter is removed.
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4.
Discard the used filter in the slot located in the wax filter kit by pressing it into the center, sliding it to one end of the slot, and pull until the filter is discarded.
5.
Flip the wax filter tool around, locate a new filter in the dial, and press the tip of the tool into the center of the dial.
6.
Gently pull the new filter out of the dial.
7.
Align the new filter to the sound outlet.
8.
Press the new filter into the opening, and simultaneously pull and rock back and forth until the new wax filter is in place.
Change wax filters
1.
To remove the old wax guard, insert the removal side of the wax guard tool into the used wax guard so that the shaft of the tool is touching the rim of the wax guard. Slowly pull the wax guard straight out.
2.
To insert the new wax guard, gently press the replacement side of the wax guard tool straight into the hole of the sound outlet until the outer ring lies flush with the outside of the receiver.
Pull the tool straight out - the new wax guard will remain in place.
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NOTE: Pressing on the new filter with the flat side of the wax filter tool can ensure that the filter is correctly in place.
If a different type of wax filter is used for your hearing aids, or if your hearing aids do not use wax filters, consult your hearing care professional for guidance.
CAUTION: Use only original consumables from the manufacturer, e.g. wax filters.
Care and maintenance
Please follow the advice below to have the best user experience and to prolong the life of your hearing aids.
1.
Keep your hearing aids dry and clean.
2.
Open the battery door to dry your hearing aids when you are not wearing them.
3.
Wipe the hearing aids with a soft cloth after use to remove grease or moisture.
4.
Do not wear your hearing aids when putting on cosmetics, perfume, aftershave, hairspray, suntan lotion, etc. These might discolor the hearing aid or get into the hearing aid, causing damage.
5.
Do not immerse your hearing aid in any liquid.
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6.
Keep your hearing aids away from excessive heat and direct sunlight. The heat may deform the shell, damage the electronics and deteriorate the surfaces.
7.
Do not swim, shower or steam bathe while wearing your hearing aids.
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Wireless accessories
ReSound’s wireless eco-system features a comprehensive range of seamlessly integrated wireless accessories. This allows you to control and stream high-quality stereo sound and speech directly to your hearing aids.
Please find the list of available wireless accessories below:
• ReSound TV Streamer 2 allows you to stream the audio from TV sets and virtually any other audio source to your hearing aids at a volume level that suits you.
• ReSound Remote Control allows you to adjust the volume, mute your hearing aids and change programs.
• ReSound Remote Control 2 allows you to adjust the volume or mute your hearing aids, change programs, and see all your settings at a glance on its display.
• ReSound Phone Clip+ streams phone conversations and stereo sound directly to both hearing aids, and it doubles as a simple remote control.
• ReSound Micro Mic is a body-worn microphone for your friend or colleague. It significantly improves speech understanding in noisy situations.
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• ReSound Multi Mic works like the ReSound Micro Mic but doubles as a table microphone, 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 ReSound wireless accessories.
For use of wireless functionality only use ReSound wireless accessories. For further guidance, please refer to the user guide of the relevant ReSound wireless accessory.
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Tinnitus Management
Tinnitus Sound Generator module
Your hearing aid includes the Tinnitus Sound Generator (TSG) module, a tool for generating sounds to be used in tinnitus management programs to temporarily relieve suffering from tinnitus. The
TSG 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 TSG module - (US only)
The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus
Management Programme 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 for children 5 years of age or older.
TheTinnitus Sound Generator Module is targeted for healthcare professionals, which are treating patients suffering from Tinnitus, as well as conventional hearing disorders. The fitting of the
Tinnitus Sound Generator Module must be done by a hearing professional participating in a Tinnitus
Management Program.
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User instructions for the TSG module
Description of device
The Tinnitus Sound Generator (TSG) 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 works
The TSG 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.
The modulation level and speed can also be configured to your likes and needs. An additional feature can be enabled by your hearing care professional to allow 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 synchronization, this functionality can be enabled by your hearing care professional. This will cause the Tinnitus Sound Generator to synchronize the sound in both hearing aids.
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If your tinnitus troubles you only in quiet environments, your doctor, audiologist or hearing care professional can set the TSG Module so that it becomes audible exclusively in such surroundings.
The overall sound level can be adjusted via a 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 synchronization is enabled your hearing care professional can also enable environmental monitoring synchronization so that the TSG 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 TSG 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 TSG 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 TSG module can also be set to mask the tinnitus sound, so to provide temporary relief by introducing a more pleasant and controllable sound source.
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TSG 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 TSG module used for adjusting the sound generator output level.
Using TSG with smartphone apps
The tinnitus sound generator control via hearing aid push buttons can be enhanced with wireless control from a TSG control app on a smartphone or mobile device. This functionality is available in supported hearing aids when a hearing care professional has enabled the TSG functionality during fitting of the hearing aid.
NOTE: To use smartphone apps, the hearing aid must be connected to the smartphone or mobile device.
Technical specifications
Audio signal technology
Digital.
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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.
High-pass filter
500 Hz
-
750 Hz
1000 Hz
1500 Hz
2000 Hz
Low-pass filter
2000 Hz
3000 Hz
4000 Hz
5000 Hz
6000 Hz
8000 Hz
Prescription use of a Tinnitus Sound Generator hearing aid
The TSG 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 TSG, please consult your hearing care professional.
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Should you develop any side effects from using the sound generator, such as dizziness, nausea, headaches, a perceived decrease in auditory function or an increase in tinnitus perception, you should discontinue using the sound generator and seek medical evaluation.
Children and physically or mentally challenged users will require training by a doctor, audiologist, hearing healthcare professional or guardian for the insertion and removal of the hearing instrument containing the TSG 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.
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Tinnitus Sound Generator warnings
1.
Sound generators should be used only as advised by your doctor, audiologist, or hearing care professional.
2.
Sound generators are not toys and should be kept out of reach of anyone who might cause themselves injury (especially children and pets).
3.
Sound generators can be dangerous if improperly used.
Tinnitus Sound Generator precautions
1.
Should the user develop any side effects from using the sound generator, such as dizziness, nausea, headaches, a perceived decrease in auditory function or an increase in tinnitus perception, the user should discontinue use of the sound generator and seek medical evaluation.
2.
Discontinue use of the sound generator and consult promptly with a licensed physician if you experience one of the following conditions: a. Visible congenital or traumatic deformity of the ear b. History of active drainage from the ear within the previous 90 days
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c. History of sudden or rapidly progressive hearing loss within the previous 90 days d. Acute or chronic dizziness e. Unilateral hearing loss of sudden or recent onset within the previous 90 days f. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal g. Pain or discomfort in the ear
3.
Discontinue use of the sound generator and consult promptly with your hearing care professional, if you experience changes in the tinnitus perception, discomfort or interrupted speech perception, while using the Tinnitus Sound Generator.
4.
The volume control is a feature in the TSG module used for adjusting the sound generator output level. To prevent unintended usage by pediatric or physically or mentally disabled users, the volume control must be configured to only provide a decrease of the sound generator output level.
5.
Children and physically or mentally disabled users will require guardian supervision while wearing the TSG hearing aid.
6.
Adjustment of the Tinnitus Sound Generator settings, using a smartphone app, should only be performed by the parent or legal guardian in cases where the user is a minor. Use of the
ReSound Assist for remote settings of the tinnitus sound generator, should only be performed by the parent or legal guardian in cases where the user is a minor.
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Tinnitus Sound Generator 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), 1,000 Hz, and
2,000 Hz
7.
Visible evidence of significant cerumen accumulation or a foreign body in the ear canal
8.
Pain or discomfort in the ear
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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 it is set to a level of 85 dB SPL or above. At levels of 90 dB SPL or above, the sound generator should not be used for more than two (2) hours daily. In no case should the sound generator be worn at uncomfortable levels.
46
General warnings
1.
Consult a hearing care professional if you think there may be a foreign object in your ear canal, if you experience skin irritation, or if excessive earwax accumulates with the use of the hearing aid.
2.
Different types of radiation, e.g., from NMR, MRI, or CT scanners, may damage hearing aids.
It is recommended not to wear hearing aids during these or other similar procedures. Other types of radiation, such as burglar alarms, room surveillance systems, radio equipment, mobile telephones, contain less energy and will not damage hearing aids. However, they have the potential to momentarily affect the sound quality or temporarily create undesired sounds from the hearing aids.
3.
Do not wear hearing aids in mines, oil fields, or other explosive areas unless those areas are certified for hearing aid use.
4.
Do not allow others to use your hearing aids.
5.
Hearing Aid usage by children or persons with a mental disability should be supervised at all times to ensure their safety. The hearing aid contains small parts that could be swallowed by children. Please be mindful not to leave children unsupervised with this hearing aid.
6.
Hearing aids should be used only as prescribed by your hearing care professional. Incorrect use may result in sudden and permanent hearing loss.
47
7.
Warning to hearing care professionals: Special care should be exercised in selecting and fitting hearing aids with maximum sound pressure level that exceeds 132dB SPL with an IEC
60711:1981 occluded ear simulator. There may be a risk of impairment of the remaining hearing.
8.
Turn off your wireless functionality by using the flight mode in areas where radio frequency emission is prohibited.
9.
If a hearing aid is broken, do not use it.
10. 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).
NOTE: For use of wireless functionality, only use supported wireless accessories.
For further guidance regarding e.g.
pairing, please refer to the user guide of the relevant wireless accessory.
48
General precautions
1.
When wireless function is activated, the device uses low-powered digitally coded transmissions in order to communicate with other wireless devices. Although unlikely, nearby electronic devices may be affected. In that case, move the hearing aid away from the affected electronic device.
2.
Use only original consumables from the manufacturer, e.g., wax guards.
3.
Only connect your hearing aids to accessories intended and qualified to be used with your hearing aids.
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 obtain 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.
49
Troubleshooting
Troubleshooting
Issue Potential cause
Feedback, "whistling" Is the volume very loud?
Are you holding an object (e.g., a hat, a telephone receiver) close to the hearing aid?
No sound
Is your ear full of wax?
Is the hearing aid turned on?
Is there a battery in the hearing aid?
Is the battery still good?
Is your ear full of wax?
Potential solution
Reduce it.
Move your hand away to create more space between the hearing aid and the object.
Visit your physician.
Switch it on.
Insert a new battery.
Replace with a new one.
Visit your physician.
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Issue
Sound is distorted or weak?
Potential cause
The battery is dead
Is the battery dirty?
Battery drains very quickly
Did your hearing aid get moist?
Did you leave your hearing aid switched on for longer periods of time?
Is the battery old?
Potential solution
Replace it with a new one.
Clean it or replace it with a new one.
Use a desiccant.
Always switch off your hearing aid when you are not using it, e.g., during the night.
Check the date on the battery pack.
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Warnings to hearing care professionals (US only)
A hearing care professional 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 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 decibels at 500 Hertz (Hz), 1,000 Hz, and
2,000 Hz.
7.
Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
8.
Pain or discomfort in the ear.
52
Important notice for prospective hearing aid users (US only)
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 care professional, as appropriate, for a hearing aid evaluation.
The audiologist or hearing care professional 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 care professional 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 care professionals 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.
53
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 (US only)
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 a child’s language development and educational and social growth. An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of a child with hearing loss.
54
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
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.
55
During normal operation, the temperature should not exceed the limit values of 0 °C (+32 °F) to
+45 °C (+113 °F), and relative humidity of 90% RH, non-condensing. Air pressure between 500 hPa and 1100 hPa is appropriate.
During transport or storage, the temperature should not exceed the limit values of -20 °C (-4 °F) to
+60 °C (+140 °F) and relative humidity of 90% RH, non-condensing (for limited time). Air pressure between 500 hPa and 1100 hPa is appropriate.
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.
56
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 receiver.
• Connect the equipment into an outlet on a circuit different from the one in 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 the US: FCC CFR 47 Part 15, subpart C.
57
• 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 ISED rules.
• 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 designations for models included in this user guide are:
This device includes an RF transmitter which operates in the frequency band of 2.4
GHz – 2.48
GHz.
Type designations
Hearing aid type designations for models included in this user guide are:
CSX12 , FCC ID:X26CSX12, IC: 6941C-CSX12; CSX13 , FCC ID: X26CSX13, IC: 6941C-CSX13;
CSI12 , FCC ID: X26CSI12, IC: 6941C-CSI12; and CSI13 , FCC ID: X26CSI13, IC: 6941C-CSI13, and
CSX10 , FCC ID: X26CSX10, IC: 6941C-CSX10.
58
This device operates in the frequency range of 2.4 GHz - 2.48 GHz. This device includes an RF transmitter that operates in the range of 2.4 GHz - 2.48 GHz.
Symbols
WARNING: Points out a situation that could lead to serious injuries.
CAUTION: Indicates a situation that could lead to minor and moderate injuries.
Advice and tips on how to handle your hearing aid better.
Equipment includes an RF transmitter.
Follow instructions for use.
Please ask your local hearing care professional concerning disposal of your hearing aid.
NOTE: Country-specific regulations may apply.
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Hearing aid variants
Completely-in-the-canal (CIC) hearing aids (including type CSX10 with FCC ID X26CSX10, IC number 6941C-CSX10 models) with size 10A battery are available in the following variants:
RE4CIC-W-HP
RE4CIC-W-LP
RE4CIC-W-MP
RE4CIC-W-UP
RE5CIC-W-HP
RE5CIC-W-LP
RE5CIC-W-MP
RE5CIC-W-UP
RE7CIC-W-HP
RE7CIC-W-LP
RE7CIC-W-MP
RE7CIC-W-UP
RE9CIC-W-HP
RE9CIC-W-LP
RE9CIC-W-MP
RE9CIC-W-UP
In-the-canal (ITC) hearing aids (including type CSI12 with FCC ID X26CSI12, IC number 6941C-
CSI12 models) with size 312 battery:
RE4ITC-DW-HP
RE4ITC-DW-LP
RE4ITC-DW-MP
RE4ITC-DW-UP
RE5ITC-DW-HP
RE5ITC-DW-LP
RE5ITC-DW-MP
RE5ITC-DW-UP
RE7ITC-DW-HP
RE7ITC-DW-LP
RE7ITC-DW-MP
RE7ITC-DW-UP
RE9ITC-DW-HP
RE9ITC-DW-LP
RE9ITC-DW-MP
RE9ITC-DW-UP
RE5ITC-DWT-HP
RE5ITC-DWT-MP
RE5ITC-DWT-UP
RE7ITC-DWT-HP
RE7ITC-DWT-MP
RE7ITC-DWT-UP
RE9ITC-DWT-HP
RE9ITC-DWT-MP
RE9ITC-DWT-UP
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In-the-ear (ITE) hearing aids (including type CSI13 with FCC ID X26CSI13, IC number 6941C-
CSI13 models) with size 13 battery are available in the following variants:
RE4ITE-DW-HP
RE4ITE-DW-MP
RE4ITE-DW-UP
RE5ITE-DW-HP
RE5ITE-DW-MP
RE5ITE-DW-UP
RE7ITE-DW-HP
RE7ITE-DW-MP
RE7ITE-DW-UP
RE9ITE-DW-HP
RE9ITE-DW-MP
RE9ITE-DW-UP
RE5ITE-DWT-HP
RE5ITE-DWT-MP
RE5ITE-DWT-UP
RE7ITE-DWT-HP
RE7ITE-DWT-MP
RE7ITE-DWT-UP
RE9ITE-DWT-HP
RE9ITE-DWT-MP
RE9ITE-DWT-UP
Mic in Helix (MIH) hearing aids (including type CSX12 with FCC ID X26CSX12, IC number
6941C-CSX12 models) with size 312 battery and Custom Mic in Helix hearing aids (including type CSX13 with FCC ID X26CSX13, IC number 6941C-CSX13 models) with size 13 battery are available in the following variants:
RE4MIH-W-HP
RE4MIH-W-MP
RE4MIH-W-UP
RE5MIH-W-HP
RE5MIH-W-MP
RE5MIH-W-UP
RE7MIH-W-HP
RE7MIH-W-MP
RE7MIH-W-UP
RE9MIH-W-HP
RE9MIH-W-MP
RE9MIH-W-UP
RE5MIH-WT-HP
RE5MIH-WT-MP
RE5MIH-WT-UP
RE7MIH-WT-HP
RE7MIH-WT-MP
RE7MIH-WT-UP
RE9MIH-WT-HP
RE9MIH-WT-MP
RE9MIH-WT-UP
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Nominal RF output power transmitted is:
CSI12 : + 1.36 dBm CSI13 : + 1.36 dBm CSX10 : + 2.5 dBm CSX12 : + 1.36 dBm CSX13 : + 1.36
dBm.
62
Additional information
Technical specifications
Hearing aid model
All Low Power (LP) models
All Medium Power (MP) models
All High Power (HP) models
All Ultra Power (UP) models
* For wireless CIC-models.
Maximum output
(Data in accordance with IEC60118-0
Edition3.0 2015-06, IEC60118-7 and ANSI
S3.22-2009, supply Voltage 1.3V)
114 dB SPL (typical)
118 dB SPL (typical)
120 dB SPL (typical)
129 dB SPL (typical); 128 dB SPL (typical)*
63
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:
* Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer.
* Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution.
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
64
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.
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.
© 2020 GN Hearing A/S All rights reserved. ReSound is a trademark of GN Hearing A/S. Apple, the
Apple logo, iPhone, iPad, iPod touch are trademarks of Apple Inc., registered in the U.S. 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.
65
Notes
66
Notes
67
Ma nufa cture r a ccording to
FDA:
Manufacturer according to
Health Canada:
GN ReSound North A merica
8001 E Bloomington Fre e wa y
Bloomington, MN 55420
USA
1-888-735-4327 re sound. com
ReSound
Government Services
8001 E Bloomington Freeway
Bloomington, MN 55420
USA
1-800-392-9932 resound.com
ReSound Canada
2 East Beaver Creek Road, Building 3
Richmond Hill, ON L4B 2N3
Canada
1-888-737-6863 resound.com
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