ReSound ONE Bedienungsanleitung

User guide

ReSound Custom hearing aids, Rechargeable

Hearing aid information

Left hearing aid Right hearing aid

Serial number Serial number

Model number Model number

Battery type Rechargeable

Program Beep Description

1 One beep

2 Two beeps

3 Three beeps

4 Four beeps

2Hearing aid information

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.

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.

4FDA warnings and cautions (USonly)

You might need medical help if a piece gets stuck in your ear

If any part of your hearing aid, like the eartip (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.

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.

FDA warnings and cautions (USonly) 5

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 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.

6FDA warnings and cautions (USonly)

Table of Contents

Hearing aid information 2

FDA warnings and cautions (USonly) 3

Introduction 8

Getting to know your hearing aid 11

Charging your hearing aids 12

Placing your hearing aids in your ears 14

Removing your hearing aids from your ears 16

Using your hearing aids 17

Advanced options 24

Wireless accessories 27

Cleaning and caring for your hearing aids 31

Tinnitus Management 37

General warnings and cautions 45

Cyber security warnings 48

Troubleshooting 49

Regulatory information 51

Technical specifications 58

Additional information 63

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:

•Visible congenital or traumatic deformity of the ear.

8Introduction

•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 9

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.

Medical Device.

NOTE: Advice and tips on how to handle

your hearing aid better.

Date of manufacture.

Follow instructions for use.

UDI

Unique Device Identification.

Equipment includes an RF transmitter. Complies with IMDA requirements.

Product is a Type B applied part. Complies with ACMA requirements.

By prescription only (US).

Do not dispose of your hearing aids and batteries with ordinary household garbage. Your hearing

aids and batteries should be disposed of at sites intended for electronic waste or returned to your

hearing care professional for safe disposal.

Please ask your local hearing care professional about the disposal of your hearing aid.

NOTE: There may be specific regulations in your country.

10 Introduction

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