Re Sound Nexia Behind The Ear Hearing Aids Rechargeable User Guide

Re Sound Nexia Behind The Ear Hearing Aids Rechargeable

Product Information

Specifications

• Type: Behind-The-Ear hearing aids, Rechargeable
• Brand: ReSound Nexia
• Programs: 1, 2, 3, 4
• Beep: One beep, Two beeps, Three beeps, Four beeps

Product Usage Instructions

Description

Provide a brief description of the product and its features.

Product Usage Guidelines

1. Follow the user manual for proper fitting and adjustment.
2. Avoid exposure to extremely loud noises.
3. Clean the hearing aids regularly following the manufacturer’s instructions.
4. Ensure the hearing aids are fully charged before use.

FAQs

• What to expect when starting to use the hearing aid?
  • It’s important to note that the hearing aid will not restore normal hearing and may not eliminate all difficulties in hearing over noise. Additionally, it will not improve underlying medical conditions causing hearing loss.
• What to do if experiencing discomfort or pain?
  • If the sound output is uncomfortably loud or painful, turn down the volume or remove the device. Consistent discomfort may require further adjustments.
• What if a part gets stuck in the ear?
  • If any part of the hearing aid gets stuck in the ear and cannot be easily removed, seek medical help immediately. Avoid using tweezers or cotton swabs as they may cause injury.

Behind-The-Ear hearing aids, Rechargeable
ReSound Nexia User guide

Hearing aid information

Left hearing aid

Serial number

Model number

Battery type

£ Rechargeable

Program 1 2 3 4

Beep One beep Two beeps Three beeps Four beeps

Right hearing aid Serial number Model number
Description

2

FDA warnings and cautions (US only)
WARNING: People younger than 18 should go to a doctor before using this People younger than 18 years old need specialized care, and using this without a medical evaluation may worsen impairment or disability. A hearing aid user who is younger than 18 should have a recent medical evaluation from a doctor, preferably an ear-nose-throat doctor (an ENT). Before using this, a doctor should determine that the use of a hearing aid is appropriate.
WARNINGS to Hearing Aid Dispensers You should advise a prospective hearing aid user to consult promptly with a doctor, preferably an ear specialist such as an ENT, before dispensing a hearing aid if you determine 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:
· Visible deformity of the ear, either congenital or traumatic · Fluid, pus, or blood coming out of the ear within the previous 6 months · Pain or discomfort in the ear. · History of excessive ear wax or suspicion that something is in the ear canal · Dizziness, either recent or long-standing · Sudden, quickly worsening, or fluctuating hearing loss within the previous 6
months
FDA warnings and cautions (US only) 3

· Hearing loss or ringing (tinnitus) only in one ear or noticeable difference in
hearing between ears
· Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz,
and 2000 Hz. Outputs over 132 dB SPL: You should exercise special care in selecting and fitting a hearing aid with a maximum output that exceeds 132 dB SPL because it may impair the remaining hearing of the hearing aid user.
Sound pressure level in the ears of children: The developed sound pressure level in the ears of children can be substantially higher than in average adults.It is recommended to perform an RECD measurement in order to ensure the correct target for the fitted OSPL90.
CAUTION: This is not hearing protection You should remove this device if you experience overly loud sounds, whether short or long-lasting. If you’re in a loud place, you should use the right kind of hearing protection instead of wearing this device. In general, if you would use ear plugs in a loud place, you should remove this device and use ear plugs.
4 FDA warnings and cautions (US only)

The sound output should not be uncomfortable or painful You should turn down the volume or remove the device if the sound output is uncomfortably loud or painful. If you consistently need to turn the volume down, you may need to further adjust your device.
You might need medical help if a piece gets stuck in your ear If any part of your hearing aid, like the ear tip (dome), gets stuck in your ear, and you can’t easily remove it with your fingers, get medical help as soon as you can. You should not try to use tweezers or cotton swabs because they can push the part further into your ear, injuring your eardrum or ear canal, possibly seriously.
NOTE:
What you might expect when you start using your hearing aid
· A hearing aid can benefit many people with hearing loss. However, you should
know it will not restore normal hearing, and you may still have some difficulty hearing over noise. Further, a hearing aid will not prevent or improve a medical condition that causes hearing loss.
· People who start using hearing aids sometimes need a few weeks to get used
to them. Similarly, many people find that training or counseling can help them get more out of their devices.
· If you have hearing loss in both ears, you might get more out of using hearing
aids in both, especially in situations that make you tired from listening ­ for example, noisy environments.
FDA warnings and cautions (US only) 5

Tell FDA about injuries, malfunctions, or other adverse events
· To report a problem involving your hearing aid, you should submit information
to FDA as soon as possible after the problem. FDA calls them “adverse events”, and they might include: skin irritation in your ear, injury from the device (like cuts or scratches, or burns from an overheated battery), pieces of the device getting stuck in your ear, suddenly worsening hearing loss from using the device, etc. Instructions for reporting are available at https://www.fda.gov/Safety/MedWatch, or call 1-800-FDA-1088. You can also download a form to mail to FDA.
Hearing loss in people younger than 18
· People younger than 18 should see a doctor first, preferably an ear-nose-
throat doctor (an ENT), because they may have different needs than adults.
· The doctor will identify and treat medical conditions as appropriate. · The doctor may refer the person to an audiologist for a separate test, a
hearing aid evaluation.
· The hearing aid evaluation will help the audiologist select and fit the
appropriate hearing aid. A person who is younger than 18 years old with hearing loss should have a medical evaluation by a doctor, preferably an ENT, before buying a hearing aid. The purpose of a medical evaluation is to identify and treat medical conditions that may affect hearing but that a hearing aid won’t treat on its own.
Following the medical evaluation and if appropriate, the doctor will provide a written statement that the hearing loss has been medically evaluated and the
6 FDA warnings and cautions (US only)

person is a candidate for a hearing aid. The doctor may refer the person to an audiologist for a hearing aid evaluation, which is different from the medical evaluation and is intended to identify the appropriate hearing aid. The audiologist will conduct a hearing aid evaluation to assess the person’s ability to hear with and without a hearing aid. This will enable the audiologist to select and fit a hearing aid for the person’s individual needs. An audiologist can also provide evaluation and rehabilitation since, for people younger than 18, hearing loss may cause problems in language development and educational and social growth. An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of hearing loss in people younger than 18.
FDA warnings and cautions (US only) 7

Introduction

Thank you for choosing ReSound hearing aids. We recommend that you use your hearing aids every day.
NOTE: Read this booklet carefully BEFORE using your hearing aids.
Intended purpose
The hearing aid is intended to compensate for hearing impairment by amplifying and transmitting sound to the ear.
User profile
· 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. · The hearing aid is intended to be fitted by qualified hearing care professionals.
Therapeutic indications
Sensorineural, conductive, or mixed hearing loss.
Contraindications
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 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:
10 Introduction

· Visible congenital or traumatic deformity of the ear. · History of active drainage from the ear within the previous 90 days. · History of sudden or rapidly progressive hearing loss within the previous 90 days. · Acute or chronic dizziness. · Unilateral hearing loss of sudden or recent onset within the previous 90 days. · Audiometric air-bone gap equal to or greater than 15 dB at 500 Hertz (Hz), 1000 Hz,
and 2000 Hz.
· Visible evidence of significant cerumen accumulation or a foreign body in the ear
canal.
· Pain or discomfort in the ear.
Side effects
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 · Skin reaction · Ear wax accumulation
Introduction 11

Symbols

WARNING: Points out a situation that could lead to serious injuries.

Legal manufacturer.

CAUTION: Indicates a situation that could lead to minor and moderate injuries.

Date of manufacture.

Follow instructions for

MD

use. (Logo in blue)

Medical Device.

Product is a Type B

UDI

Unique Device

applied part.

Identification.

Equipment includes an RF transmitter.

IMDA label for Singapore.

Regulatory compliance mark for Australia and New Zealand.

By prescription only (US).

Do not dispose of electronic devices or batteries with ordinary household waste. They should be disposed of at sites intended for electronic waste or returned to your hearing care professional for safe disposal. Please note: There may be specific regulations in your country.

12 Introduction

Getting to know your hearing aid

BTE models with hook
1. Earmold 2. Tube 3. Microphone inlets 4. LED green indicator light
(See page 23) 5. Push button 6. Left/Right identification
Left = blue. Right = red. 7. Model and serial number. NOTE: Use only original consumables from ReSound, e.g. tubes.
Getting to know your hearing aid 13

BTE Thin tube model
1. Dome 2. Thin tube 3. Microphone inlets 4. LED green indicator
light (See page 23) 5. Push button
Open dome is shown. Yours may look different. NOTE: Use only original consumables from ReSound, e.g. tubes and domes.
14 Getting to know your hearing aid

Charging your hearing aids

We recommend that you charge your hearing aids fully before using them. This is just a precaution to make sure that you don’t run out of power unexpectedly. To learn how to charge your hearing aids, please consult the user guide for your hearing aid charger.
Battery warnings
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.
Charging your hearing aids 15

· Batteries are harmful for the environment. Therefore, never try to burn them.
Dispose of your used rechargeable hearing aids according to your country’s regulations or return them to your hearing care professional.
· For safety reasons, only use the charger provided with your hearing aids. · When traveling, consult your airline about any rules for transportation of your
hearing aid and charger.
Low battery alert
When the batteries are low on power, the volume in your hearing aids will momentarily reduce and a melody will play every 15 minutes until there is no more power – then your hearing aids will turn off.
16 Charging your hearing aids

Placing your hearing aids in your ears

How to tell left from right

Left hearing aid (blue marking)

Right hearing aid (red marking)

Color marking shown here

Model with hook shown as example. Thin-tube models are color indicated in the same way.
CAUTION: If you have two hearing aids, they may each be programmed differently. Do not swap them as this could damage your hearing. Your hearing aids are color-coded. Left = blue. Right = red. If your hearing aids are not color coded, ask your hearing care professional to add color coding.
Placing your hearing aids in your ears 17

Inserting earmolds into your ears

1. Hold the earmold between your thumb and index finger and position its sound outlet in your ear canal.
2. Slide the earmold all the way into your ear with a gentle, twisting movement.

3. Turn the top part of 4. Place the hearing aid

the earmold gently

firmly behind the ear

backwards and

and make sure it sits

forwards so it tucks

securely. When

behind the fold of skin properly inserted,

above your ear canal.

your hearing aids

Move the earmold up

should fit snugly and

and down and gently

comfortably.

press to place it

correctly in the ear.

18 Placing your hearing aids in your ears

NOTE: It may be helpful to pull your ear up and outward with your opposite hand during insertion. By experimenting, you may discover an easier method.
CAUTION: Never attempt to modify the shape of the hearing aid, earmolds, or tubing yourself.
Inserting the dome into your ear
If your hearing aids have domes, follow these instructions:

1. Hang the hearing aid over the top of your ear.

2. Hold the tube where it bends and gently place/push the dome into your ear canal.

3. Push the dome far enough into your ear canal so that the tube rests against your head. You can check in a mirror.

Placing your hearing aids in your ears 19

NOTE:
·

To avoid whistling, ensure that the tube and dome fit correctly into your ear. If you continue to experience whistling, check the troubleshooting guide for other possible reasons and solutions.

CAUTION: Never attempt to bend or modify the shape of the tube.
Domes

Tulip dome Closed dome
Domes are all light grey.

Open dome Power dome

The sport lock helps keep your hearing aids in place when you are physically active.

Thin tube

20 Placing your hearing aids in your ears

Sports lock

Removing your hearing aids from your ears

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

1. Lift the hearing aid from behind your ear. Let it hang beside your ear momentarily.

2. Using your thumb and index finger, gently pull the earmold (not the hearing aid or the tube) loose from your ear. Remove the earmold completely by twisting it gently.

Removing your hearing aids from your ears 21

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

1. Lift the hearing aid off your ear.

2. Hold the tube with your thumb and index finger where it bends and pull the dome out of your ear canal.

22 Removing your hearing aids from your ears

Using your hearing aids
Turning your hearing aids on and off
To turn your hearing aids on or off, press the push button for 5 seconds.
Pressing the button for different lengths of time enables other functions such as flight mode and streaming. These are described elsewhere in this manual.
Your hearing aids will automatically go into sleep mode when you place them in the turned-on charger, and they will automatically reactivate when you remove them from the turned-on charger.
Your hearing aids always start in program 1 at the pre-set volume.
NOTE: If the charger is disconnected during use, the hearing aids in the charger will turn off.
Explanation of LED indicator lights on the hearing aid
· 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.
Using your hearing aids 23

· When the hearing aid is present in the charger, green indicator lights pulsate: The
hearing aid is recharging.
· When the hearing aid is present in the charger, green indicator lights are on without
blinking: The hearing aid is fully charged.
Smart Start
Smart Start delays the time before your hearing aid turns on after you remove the hearing aid from the charger. With this function activated, you will hear a beep for each second of the delay period (either 5 or 10 seconds).
NOTE: If you do not want to use this function, ask your hearing care professional to deactivate it.
Adjusting the volume
Your hearing aid automatically adjusts the volume depending on your listening situation. You can also adjust the volume by means of a ReSound remote control or the ReSound Smart 3DTM app. (Optional). 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.
24 Using your hearing aids

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 the volume in one of the hearing aids, it responds with one or more beeps. A beep in the second hearing aid follows.

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.

Using your hearing aids 25

Programs All-Around Hear in Noise
Music Acoustic phone Outdoor Telecoil phone + Mic Telecoil loop + Mic

Use The best option if you want only one program. Dedicated program for hearing speech in very noisy places such as restaurants or social gatherings. For listening to music. A special program for phone conversations. For outdoor use (to reduce wind noise). For use if you have a phone with a telecoil. For use in places that have a teleloop system such as theaters and places of worship.

Apps We have an app that you can use to control your hearing aids. You can use the app to adjust the volume, change programs and stream from another device. See “Advanced options”, page 31.

26 Using your hearing aids

Changing program
Your hearing aid has a push button which allows you to select from several listening programs.
Push the button to change program. You will then hear one or more beeps. The number of beeps indicates which program you have selected (one beep = program 1, two beeps = program 2 and so on).
You can also change programs using a ReSound remote control or the ReSound Smart 3DTM app.

NOTE:
·
·

If you have two hearing aids with synchronization enabled, changing the program on one hearing aid automatically applies the change to the second hearing aid as well. The same number of beeps will then sound in the second hearing aid.
When you turn the hearing aids off and on again, they always start up in program 1 and at your pre-set volume level.

Using your hearing aids 27

Using teleloop systems with your hearing aid
Telecoil (Optional) The Telecoil function may help to improve understanding of speech with Hearing Aid Compatible (HAC)1 telephones and in theaters, movie theaters, 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 (i.e., 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. When you want to stop the telecoil function, change to another listening program.

1 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.
28 Using your hearing aids

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 29

NOTE:
·
·

If you have a mobile device, you can pair it to connect directly to your hearing aids. See “Advanced options”, page 31. If you find it difficult to get a good result while using your mobile phone, your hearing care professional can give you advice on available wireless accessories to enhance listening capabilities. See also “Wireless accessories”, page 35.

30 Using your hearing aids

Advanced options
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, including hands-free phone calls from the latest iPhone and iPad models1, and control from these mobile devices.
Streaming from an AndroidTM smartphone
Some Android smartphones can stream audio, including phone calls, 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 or visit our support site. See the back page of this user guide.
1Hands-free calls are compatible with iPhone 11 or later, iPad Pro 12.9-inch (5th generation), iPad Pro 11-inch (3rd generation), iPad Air (4th generation), iPad mini (6th generation), iPad (10th generation) or later, with software updates iOS 15.3 and iPadOS 15.3 or later.
Advanced options 31

Controlling your hearing aids with the mobile device app (optional)
The ReSound Smart 3DTM app enables you to control your hearing aids from mobile devices. You can use the ReSound Smart 3DTM app designed for your hearing aids to obtain updates to your hearing aids, find your hearing aids, check their battery status, or as a remote control to change programs or adjust the volume.

CAUTION:
· Only connect your hearing aid to the official ReSound mobile device app. · The app must only be used with ReSound hearing aids for which they are
intended, and ReSound takes no responsibility if the app is used with other
hearing aids.
· Do not disable app notifications. · Install updates to keep the app working correctly.

NOTE:
·
·

If you want a printed version of the user guide for the app, please go to our website (see the back page of this user guide) or consult customer support. For assistance with pairing and using these products with your hearing aids, contact your hearing care professional or visit our support site.

32 Advanced options

· If your Bluetooth® enabled Android mobile device does not stream directly to
your hearing aids, you can use our ReSound Phone Clip+ for streaming capabilities and for hands-free conversations.
ReSound Assist and ReSound Assist Live (optional)
ReSound Assist 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 visit your hearing care professional. All you need is a compatible mobile device with internet enabled. This allows you to:
· Request assistance remotely to adjust your hearing aids to be a better fit for you. · Keep your hearing aids up to date with the latest software to ensure the best
performance possible. This service only works if your mobile device is connected to the internet. Your hearing care professional will provide information regarding this option, and how it works with the ReSound Smart 3DTM app.
Advanced options 33

For optimum performance, make sure the hearing aids are connected to the ReSound Smart 3DTM app and placed close to the iPhone, iPad, iPod touch, or the Android smartphone before applying the changes. NOTE: Your hearing aids shut down during the installation and update process. ReSound Assist Live This service also includes ReSound Assist Live. With this service you can get face- to-face assistance from your hearing care professional from home.
34 Advanced options

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.
Available wireless accessories and their features
· A TV streamer streams audio from a TV and most other audio sources to your
hearing aids at a volume that suits you.
· A basic remote control adjusts volume, mutes your hearing aids, and changes
programs.
· An advanced remote control adjusts volume, mutes your hearing aids, changes
programs, and displays your settings.
· A phone clip streams phone conversations and stereo sound to both hearing aids
and doubles as a remote control.
· A body-worn microphone is a microphone that can be worn by others. It improves
speech comprehension in noisy situations.
· A wireless microphone. It works like the body-worn microphone, but doubles as a
table microphone. Furthermore, it has a built-in telecoil that allows it to connect with a teleloop system, a connector for an FM receiver, and a mini- jack input for wired streaming of audio from a computer or music player.
· An app which you can install on your mobile device to enable streaming and control
directly from your mobile device. See “Advanced options”, page 31.
Wireless accessories 35

Accessing wireless accessories

To access a wireless accessory that has already been paired with your

hearing aids, press the push button for 2 seconds. The hearing aid will emit a

sound to confirm the connection.

2

For information on how to pair your hearing aids with a wireless accessory, see the user guide for the relevant wireless accessory.

NOTE:
·
·

Please contact your hearing care professional for an overview of compatible wireless accessories that are approved by GN Hearing A/S. You should only use ReSound wireless accessories with your wireless hearing aids.

Low battery alert when paired with wireless accessories

NOTE:
·

Your batteries will run out 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.

36 Wireless accessories

Battery level Fully charged Low
Depleted

Signal
4 even tones 3 even tones
and 1 longer tone

Hearing aid P P

Remote control P P

P

x

You can check the battery status in the ReSound Smart 3DTM app.

Streaming P x
x

Wireless accessories 37

Flight Mode / Wireless Communication Off Mode
Your hearing aids can receive wireless signals. For example, they can be controlled from your mobile device or remote control. Information transmission can also take place between your hearing aids. 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.
· Turn off hearing aid wireless functionality when this is required.
NOTE: You must follow the processes below for both hearing aids, even if synchronization is enabled.
Turning off wireless communication (activating Flight Mode)
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)
1. Turn your hearing aid off and then on. 2. Wireless communication will be activated after 10 seconds.
38 Wireless accessories

Cleaning and caring for your hearing aids
Cleaning tools
These cleaning tools come with your hearing aids:
1. Soft cloth. 2. A brush with a battery magnet. 3. A cleaning wire (not shown). Your hearing care professional may give you a set of wax filters.
Cleaning and caring for your hearing aids 39

General instructions for care and maintenance
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. 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 discolor your hearing aids.

NOTE:
· · ·

Never immerse your hearing aids in liquid. Keep your hearing aids away from excessive heat and direct sunlight. The hearing aid is dust, splash, and water resistant:

­ The hearing aid has IP6X dust resistance. Avoid exposure to extensive dust.

­ The hearing aid has IPX8 water resistance. Avoid exposure to liquids, and do not swim, shower or sauna while wearing the device.

40 Cleaning and caring for 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.

1. Wipe your hearing aids with the 2. Swipe the small brush across the

cloth.

microphones.

Cleaning and caring for your hearing aids 41

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.

The earmold

If your hearing aids have earmolds, follow these instructions:

1. Remove the earmold and tubing

3. After cleaning, dry the earmolds

from the hearing aids prior to

thoroughly and remove any residual

cleaning.

water and debris from the tubing

2. Clean the earmold using a mild soap, and rinse with lukewarm water.

utilizing a small blower and wire loop.

NOTE: Your earmold tubing may become stiff, brittle or discolored over time. Contact your hearing care professional regarding tube changes.
42 Cleaning and caring for your hearing aids

Thin tubes and domes
If your hearing aids have domes, follow these instructions: 1. Wipe down thin tubes and domes with a damp cloth. 2. If you think that the thin tubes are clogged, remove them from the hearing aids
by carefully pulling the connectors off the hearing aids. This may require a bit of force. 3. Also remove the dome. See “Changing your hearing aid domes”, page 44. 4. In order to clear the thin tube of moisture and debris, push the black cleaning wire through the thin tube, beginning at the top end of the thin tube. NOTE: We recommend that you change the domes every three months.
Cleaning and caring for your hearing aids 43

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.

NOTE:
·

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, wax filter or other object stuck in your
ear, consult your hearing care professional. These objects can be harmful and can cause an infection in your ear.
· Use only accessories intended for use with your hearing aids. Consult your
hearing aid professional for more information.

44 Cleaning and caring for your hearing aids

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

1. Remove the used dome by pulling it off the ribbed end and then discard it. This may require a bit of force.

2. Push the new dome over the outer rib.

3. Check that the dome is securely mounted by carefully lifting the lower part of the dome and verifying that the collar completely covers the ribbed end.

4. OK.

NOTE: Change the dome at least every three months. Ask your hearing care professional for advice.

Cleaning and caring for your hearing aids 45

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

1. Remove the used dome by pulling it off the ribbed end and then discard it. This may require a bit of force.

2. Push the largest petal back, then press the tulip dome over the ribbed end.

46 Cleaning and caring for your hearing aids

3. Check that the tulip dome is securely mounted by verifying that the collar completely covers the ribbed end of the receiver.

4. Push the larger petal forward.

This illustration shows a correctly mounted tulip dome. Ensure the large petal is outside the small petal.

Cleaning and caring for your hearing aids 47

Changing the microphone filter
The two microphones on the back of your hearing aid are protected by a microphone filter. If you experience sound deterioration or increased difficulty identifying where the sounds come from, changing the filters may help. You will need a box of microphone filters. Contact your hearing care professional. The microphone filter tool has two functions: a removal tip to collect the used filter, and a replacement tip with a new filter.
Box of 8 microphone filter tools.
Removing the old microphone filter 1. Open the filter case and take out one of
the tools. Each tool has a small hook (removal tip) in one end and a new microphone filter in the other.
48 Cleaning and caring for your hearing aids

2. Insert the removal tip into the used microphone filter and then pull the tool straight out. It is important to pull it straight and not on an angle.
Cleaning and caring for your hearing aids 49

Inserting the new microphone filter

1. Insert the other end of 2. Gently press the

the tool (the end with

replacement filter

the replacement filter) straight into the

into the microphone

microphone opening

opening.

until the outer ring is

flush with the back of

the hearing aid.

3. Pull the tool straight out. Your new microphone filter should remain in place.

NOTE: Pressing on the new microphone filter with the flat side of the filter tool can ensure that the filter is correctly in place.
CAUTION: Use only accessories intended for use with your hearing aids. Consult your hearing aid professional for more information.
Storing your rechargeable hearing aids
When not in use, place your hearing aids in the plugged-in charger and charge them, so they are ready for use when you need them.
50 Cleaning and caring for your hearing aids

If the hearing aids are not to be used for some time, place them in the charger while it is plugged into a power outlet. Then remove the charger from the power outlet. Both the charger and the hearing aids will turn off. If you don’t want to store the hearing aids in the charger, you can also just turn them off manually.
Cleaning and caring for your hearing aids 51

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
· See also “Contraindications”, page 10 · Never leave children, or people with cognitive, intellectual, or mental health
challenges unsupervised while using their hearing aids. Hearing aids contain small pieces that can be dangerous if swallowed.
· Swallowing a hearing aid can result in choking, and can be harmful to your
health.
· If any part of a hearing aid is swallowed, seek immediate medical attention. · Do not wear your hearing aids while being exposed to radiation. Some types of
radiation, such as 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, metal detectors, and radio equipment will not damage your hearing aids. However, they may 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 locations unless these areas are certified for hearing aid use.
52 General warnings and cautions

Using your hearing aids in places that are not certified for hearing aid use can be dangerous.
· 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.
· No modification of this device is allowed.
Warnings related to power hearing aids
· A power hearing aid can produce very loud sound to compensate for a severe
or profound hearing loss. Therefore, there is risk of further impairing the remaining hearing.
· Your hearing aids have been customized 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.
CAUTION:
· Use your hearing aids as your hearing care professional recommends.
Incorrect use may damage your hearing.
· Do not use a broken or modified 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.
General warnings and cautions 53

· Use only original consumables from ReSound, e.g. tubes and earmolds or
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 each be programmed differently. Do not
swap them as this could damage your hearing. Your hearing aids are colorcoded. Left = blue. Right = red. If your hearing aids are not color coded, ask your hearing care professional to add color coding.
· 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 a 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.
54 General warnings and cautions

For hearing care professionals CAUTION: Do not change the outer casing or any parts of a hearing aid unless appropriately protected against ESD.
General warnings and cautions 55

Cyber security
Failing to follow these precautions can compromise the information security of your hearing aid and potentially cause hearing loss or tinnitus.
CAUTION:
· Only connect your hearing aid to a trusted computer or mobile device, or one
used by a hearing care professional.
· For 3 minutes after being turned on, your hearing aid is open to connections.
Do not restart your hearing aid if requested by someone you don’t trust as this may compromise the safety of your device.
· If your device plays the pairing sound at an unexpected time, this could
indicate someone has gained access to your device.
· Only connect your hearing aid to the official ReSound mobile device app. · Only apply remote fine tuning updates that you are expecting. · Always use the latest available software update for your hearing aid. · Only accept live assistance calls from the hearing care professional that you
are expecting.
56 Cyber security

Troubleshooting

Issue Feedback, “whistling”
No sound

Potential cause

Potential solution

Is your earmold or dome

Put it back in.

inserted correctly in the ear?

Is the volume very loud?

If you have turned up the volume, try turning it down.

Are you holding an object (e.g., a hat or a phone) close to a 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 hearing care professional or doctor to have your ears checked for wax. Some people experience more wax after being fitted with hearing aids.

Is the hearing aid turned off? Turn it on.See “Using your hearing aids”, page 23.

Is the hearing aid in telecoil Switch to the microphone

mode?

program.

Is the hearing aid charged?

Place the hearing aid in the charger for charging. (See the

Troubleshooting 57

Issue
Sound is distorted or weak Battery runs out very quickly
Hearing aid is not charging

Potential cause

Potential solution

user’s guide for your charger.)

Is the plastic tube, earmold, Consult your hearing care or dome clogged or broken? professional.

Is your ear full of wax?

Visit your doctor.

Is the plastic tube, earmold, Consult your hearing care or dome clogged or broken? professional.

Did your hearing aid get damp?

Use a desiccant (drying kit).

Did you leave your hearing aid turned on for long periods of time?

Always place your hearing aids in the charger for recharging when you are not using them, e.g. during the night, or switch them off.

Is the hearing aid old?

Visit your hearing care professional.

Does the hearing aid sit correctly in the charger?

Put the hearing aid back in the charger.

Is the hearing aid charger

Plug the charger into a power

plugged into a power source? source. (See the user’s guide

for your charger.)

58 Troubleshooting

Issue
Still having an unresolved issue?

Potential cause

Potential solution
Consult your hearing care professional.

Troubleshooting 59

Tinnitus Management
Tinnitus Sound Generator module
Your ReSound 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
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 for 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 their guardian in the insertion and removal of the hearing aid containing the TSG module.
60 Tinnitus Management

For healthcare professionals
The Tinnitus Sound Generator 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 Sound Generator 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 Sound Generator 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 TSG module
Description of the 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 functions
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 in order to make 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
Tinnitus Management 61

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.
If your tinnitus only troubles you 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 using 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 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.
62 Tinnitus Management

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.
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 with the smartphone or mobile device.
Tinnitus Management 63

TSG –

Technical specifications

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

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

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

WARNING Prescription use of this device
The TSG 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 TSG, please consult your hearing healthcare professional.
64 Tinnitus Management

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 for 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 their guardian in the insertion and removal of the hearing aid 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.
Tinnitus Management 65

The sound generator instrument is a tool to generate sounds to be used with appropriate counseling 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, 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.
· Discontinue use of the sound generator and consult promptly with a licensed
physician if you experience 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.
66 Tinnitus Management

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.
· 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.
· 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, 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 TSG hearing aid.
· 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.
Tinnitus Management 67

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),
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.
68 Tinnitus Management

CAUTION: The maximum output of the sound generator falls into the range that can cause hearing loss according to OSHA regulations. In compliance 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. When the sound generator is set to levels of 90 dB SPL or above, the user should not use it for more than two (2) hours per day. In no case should the sound generator be worn at uncomfortable levels.
Tinnitus Management 69

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.
Ambient conditions
Temperature test 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.
70 Regulatory information

During use During normal operation the temperature should not exceed the limit values of +5 °C (+41 °F) ­ +40 °C (104 °F) at a relative humidity range of 15% to 90%, non-condensing, but not requiring a water vapor partial pressure greater than 50 hPa. An atmospheric pressure between 700 hPa and 1060 hPa is appropriate. While charging, the ambient temperature should be within the limit values of +5°C (+41°F) ­ +35°C (+95°F). Charging your hearing aids at ambient temperatures over +35°C (+95°F) may lead to extended charging times.
NOTE: During use, your hearing aids may reach temperatures up to +43°C (+109°F). During transport or storage During transport or storage, the temperature should not exceed the limit values of:
· -25°C (-13°F) ­ +5°C (41°F) · +5°C (+41°F) ­ +35°C (+95°F) at a relative humidity up to 90 %, non-condensing · >+35°C (+95°F) ­ +60°C (+140°F) at a water vapor pressure up to 50 hPa.
Warm-up time: 5 minutes. Cool-down time: 5 minutes.
Regulatory information 71

Expected service lifetime
The expected service lifetime for the product when used as intended is:

Product Hearing aid Built-in rechargeable battery Dome Sound tube Ear hook Earmold, soft (silicone) Earmold, hard (acrylic) Electronic accessories (e.g., wireless accessories)

Lifetime 5 years 5 years 3 months 2 years 2 years 2 years 5 years 5 years

Non-clinical testing (US only)
The devices covered within this user guide have undergone tests for the relevant nonclinical performance testing and biological endpoints in accordance with standards identified below:
· Electrical safety testing is performed according to IEC 60601-1:2005 +
A1:2012+A2:2020, IEC 60601-2-66:2019, IEC 60601-1-11 Edition 2.0 2015-1, IEC 62133-2 Edition 1.0 2017- 02 and IEC 62368-1:2018/COR1:2020.

72 Regulatory information

· Electromagnetic compatibility (EMC) testing is performed according to IEC
62479:2010, ANSI IEEE C63.19-2019 and IEC 60601-1-2:2014+A1:2020.
· Radio and Telecommunication testing is performed to be in compliance with
applicable parts of the FCC rules in title 47 of the CFR.
· Electroacoustic testing is performed according to ANSI/ASA S3.22-2014 and ANSI/CTA
2051:2017
· Usability Engineering was performed in compliance with IEC 62366-1:2015
The devices covered in this user guide passed all tests for the relevant non- clinical performance testing and biological endpoints, namely cytotoxicity (ISO 10993-05:2009), sensitization, and intracutaneous reactivity (ISO 10993-10:2010).
Similarly, usability testing and software verification and validation demonstrated mitigation of risks to an acceptable level as well as reasonable assurance of safe and effective device performance.
Clinical data (US only)
The devices have been evaluated clinically through equivalence, and the devices have been compared to equivalent devices and similar devices on the market with similar intended purpose, e.g., to compensate for hearing impairment by amplifying and transmitting sound to the ear.
Based on technical and clinical data presented for the device in question, the equivalent predecessor and generally similar devices, it is concluded to support the clinical performance expressed in user needs and claims.
Regulatory information 73

The clinical data leaves no questions open regarding clinical performance and is for this reason deemed sufficient.
Statement
This device complies with part 15 of the FCC rules and ISED rules. Its 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 according to 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:
­ Redirect or relocate the receiving antenna. ­ Increase the separation between the equipment and the receiver
74 Regulatory information

­ Connect the equipment to an outlet or a circuit that is 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 the EU: The device conforms to the General Safety and Performance Requirements
according to Annex I of the EU Medical Device Regulation 2017/745 (MDR).
· Hereby, GN Hearing A/S declares that the radio equipment type CABR70 is in
compliance with Radio Equipment Directive 2014/53/EU (RED).
· The full text of the EU declaration of conformity is available at the following internet
address: www.declarations.resound.com/en.
· In the US: FCC CFR 47 Part 15, subpart C. · In Canada: these hearing aids are certified under the rules of ISED. · Japanese Radio Law and Japanese Telecommunications Business Law Compliance:
This device has been certified pursuant to the Japanese Radio Law ( ) and the Japanese Telecommunications Business Law ( ). This device should not be modified (otherwise the granted designation number will become invalid).
· For other international regulatory requirements, please refer to the regulatory
requirements of the specific country.
Regulatory information 75

Type designations
Hearing aid type designations for models included in this user guide are CABR70, FCC ID: X26CABR70, IC6941C-CABR70.
Hearing aid variants
Availability of models may vary by country. Mini Behind-the-ear (Mini BTE) hearing aids of type CABR70 with FCC ID X26CABR70, IC number 6941C-CABR70, and a Li-Ion rechargeable battery are available in the following variants: NX971-DWC, NX771-DWC, NX571-DWC, NX471-DWC. Behind-the-ear (BTE) hearing aids of type CABR70 with FCC ID X26CABR70, IC number 6941C-CABR70, and a Li-Ion rechargeable battery are available in the following variants: NX977-DWC, NX777-DWC, NX577-DWC, NX477-DWC. This device transmits and receives RF signals in the frequency range of 2.4 GHz 2.48 GHz. Nominal RF output power transmitted at 2.4 GHz is: 4 dBm. The device contains 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. Charging output power at 333 kHz is: 300 mW.
76 Regulatory information

Technical specifications
Mini BTE
Models: NX971-DWC, NX771-DWC, NX571-DWC, NX471-DWC.
Reference test gain (60 dB SPL input) Full-on gain (50 dB SPL input)
Maximum output (90 dB SPL input)
Total harmonic distortion
Telecoil sensitivity (1 mA/m input) HFA – SPLIV @ 31.6 mA/m (ANSI) Full-on telecoil sensitivity @ 1 mA/m Equivalent input noise, w/o noise reduction 1/3 Octave Equivalent input noise, w/o noise reduction Frequency range IEC 60118-0: 2015
Battery lifetime (Battery type Rechargeable)*

HFA Max. HFA Max. HFA 500 Hz 800 Hz 1600 Hz 3200 Hz Max. HFA HFA
Typical Max.

Thin tube
35
51 44
122 111
0.2 0.1 0.4 0.3
82 96 76
22 9
1006980
24 30

Closed 42
58 51
125 118 0.3 0.7 0.4 0.1
89 102 81
20 10
100-6380
24 30

dB dB dB SPL
%
dB SPL dB SPL
Hz Hours

Output (dB SPL) Gain (dB)

Maximum Output (OSPL 90)
140 130 120 110 100
90 80
Frequency (Hz)

Full-On and Reference Test Gain
70

60 Full-on gain

50

50 dB SPL input

40

30 Reference test gain

20

60 dB SPL input

10

Frequency (Hz)

Black curve: Thin tube; Grey curve: Closed

Data in accordance with ANSI S3.22-2014, IEC 60118-0:2015. Measured in a 2cc coupler. * The expected operating time of the rechargeable battery depends on active features, the use of wireless accessories, hearing loss, battery age and sound environment.

Technical specifications 77

Mini BTE (US only)
Additional technical data
Latency, mid frequency delay (2 kHz) Battery current drain, Thin tube Battery current drain, Closed/Hook Attack/release time (2 kHz syllabic)

5.1 ms 0.4 mA 0.4 mA 12 / 70 ms

Input/Output response, measured in a 2cc coupler at the reference test gain @ 2

KHz

Input/Output Response – Thin Tube

130

Ref.Test Gain @ 2 kHz

Input/Output Response – Hook

140

Ref.Test Gain @ 2 kHz

120

130

Output (dB SPL) Output (dB SPL)

110 2cc coupler
100

120
2cc coupler 110

90

100

80

90

70

40

50

60

70

80

90

100

Input (dB SPL)

80

40

50

60

70

80

90

100

Input (dB SPL)

78 Technical specifications

BTE

Models: NX977-DWC, NX777-DWC, NX577-DWC, NX477-DWC.
Reference test gain (60 dB SPL input) Full-on gain (50 dB SPL input) Maximum output (90 dB SPL input) Total harmonic distortion

Telecoil sensitivity (1 mA/m input) HFA – SPLIV @ 31.6 mA/m (ANSI) Full-on telecoil sensitivity @ 1 mA/m Equivalent input noise, w/o noise reduction 1/3 Octave Equivalent input noise, w/o noise reduction
Frequency range IEC 60118-0: 2015
Battery lifetime (Battery type Rechargeable)*

Output (dB SPL) Gain (dB)

Maximum Output (OSPL 90)
140 130 120 110 100
90 80
Frequency (Hz)

Full-On and Reference Test Gain
70

60 Full-on gain

50

50 dB SPL input

40

30 Reference test gain

20

60 dB SPL input

10

Frequency (Hz)

HFA Max. HFA Max. HFA 500 Hz 800 Hz 1600 Hz 3200 Hz Max. HFA HFA
Typical Max.

Thin tube
40
53 47 127 116 0.1 0.1 0.7 0.4 85 100 78
22 9
1006990
24 30

Closed
45
60 53 128 122 0.3 0.7 0.6 0.2 91 105 83 20 10 100-6240
24 30

dB dB dB SPL
%
dB SPL dB SPL
Hz Hours

Black curve: Thin tube; Grey curve: Closed

Data in accordance with ANSI S3.22-2014, IEC 60118-0:2015. Measured in a 2cc coupler. * The expected operating time of the rechargeable battery depends on active features, the use of wireless accessories, hearing loss, battery age and sound environment.

Technical specifications 79

BTE (US only)
Additional technical data
Latency, mid frequency delay (2 kHz) Battery current drain, Thin tube Battery current drain, Closed/Hook Attack/release time (2 kHz syllabic)

5.1 ms 0.5 mA 0.5 mA 12 / 70 ms

Input/Output response, measured in a 2cc coupler at the reference test gain @ 2

KHz

Input/Output Response – Thin Tube

130

Ref.Test Gain @ 2 kHz

Input/Output Response – Hook

140

Ref.Test Gain @ 2 kHz

120 2cc coupler
110
100

130
120 2cc coupler
110

Output (dB SPL) Output (dB SPL)

90

100

80

90

70

40

50

60

70

80

90

100

Input (dB SPL)

80

40

50

60

70

80

90

100

Input (dB SPL)

80 Technical specifications

Additional information

Acknowledgements
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 TORT (INCLUDING NEGLIGENCE OR OTHERWISE)
Additional information 81

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. © 2024 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. 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.
82 Additional information

Notes
Additional information 83

402585011US_CA_VA- 24.01 – Rev. B (Date of issuance: 2024.01.01)

Manufacturer according to EU Medical Device Regulation 2017/745:
GN Hearing A/S Lautrupbjerg 7 DK-2750 Ballerup Denmark

Manufacturer according to FDA:

Manufacturer according to Health Canada:

GN ReSound North America 8001 E Bloomington Freeway Bloomington, MN 55420 USA 1-888-735-4327 resound.com

ReSound Canada 2 East Beaver Creek Road, Building 3 Richmond Hill, ON L4B 2N3 Canada 1-888-737-6863 resoundpro.com

ReSound Government Services 8001 E Bloomington Freeway Bloomington, MN 55420 USA 1-800-392-9932 resound.com/veterans

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

References

• ReSound hearing aids and wireless accessories | ReSound US
• Hearing aids for veterans - we support you | ReSound US
• Hearing aids by ReSound - rechargable and streaming audio directly from AndroidTM and iOS devices
• declarations.resound.com/en
• MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA

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