GN Hearing Flyte DA312r Bedienungsanleitung

User Guide Flyte Custom

User Guide Flyte BTE

400847011US-17.10-Rev.A 1 02-10-2017 14:14:51

Hearing instrument type designations for models included in this user guide are: DA312r, FCC ID:

X26DA312r, IC: 6941C-DA312r; DA13r, FCC ID: X26DA13r, IC: 6941C-DA13r; DA312i, FCC ID: X26DA312i,

IC: 6941C-DA312i; and DA13i, FCC ID: X26DA13i, IC: 6941C-DA13i. Please see page 10, 12 and 14 for lists

of models referring to these types.

Statement:

This device complies with part 15 of the FCC rules and ICES-003 of the ISED rules. Operation is subject to

the following two conditions:

(1) this device may not cause harmful interference, and

(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, pur-

suant to part 15 of the FCC Rules and ICES-003 of the ISED rules. These limits are designed to provide rea-

sonable 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 televi-

sion 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 con-

nected.

• Consult the dealer or an experienced radio/TV technician for help.

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

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The products are in compliance with the following regulatory requirements:

• In the EU: the device conforms to the Essential Requirements according to Annex I of Council Directive

93/42/EEC for medical devices (MDD) and essential requirements and other relevant provisions of Direc-

tive 2014/53/EU (RED).

• The declaration of conformity may be consulted at www.resound.com

• In US: FCC CFR 47 Part 15, subpart C.

• Other identiﬁed applicable international regulatory requirements in countries outside the EU and US.

Please refer to local country requirements for these areas.

• In Canada: these hearing instruments are certiﬁed under the rules of ISED.

• Japanese Radio Law and Japanese Telecommunications Business Law Compliance. This device is

granted pursuant to the Japanese Radio Law (電波法) and the Japanese telecommunications Business

Law (電気通信事業法) This device should not be modiﬁed (otherwise the granted designation number

will become invalid).

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.

Maximum RF output power transmitted is up to 0 dBm.

Intended use

Generic air-conduction hearing instruments are wearable sound-amplifying devices intended to compen-

sate for impaired hearing. The fundamental operating principle of hearing instruments is to receive, amplify,

and transfer sound to the ear drum of a hearing impaired person.

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Prescription use of a Tinnitus Sound Generator (TSG) hearing

instrument

The TSG module should be used as prescribed by your doctor, audiologist or hearing healthcare profes-

sional.

In order to avoid permanent hearing damages, the maximum daily usage depends on the level of the

generated sound. 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.

The target population is primarily the adult population over 18 years of age. This product may also be used

with children 5 years of age or older. However, children and physically or mentally challenged users will re-

quire training by a doctor, audiologist, hearing healthcare professional or the 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, otolo-

gists or otorhinolaryngologists.

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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 programme to relieve patients suffering from tinnitus.

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Introduction

Congratulations on the purchase of your new hearing instruments. The innovative sound technology and

design, combined with the customised device programming selected by your hearing care professional, will

make hearing a more enjoyable experience. Hearing instruments will enable you to hear sounds that you

may not have heard in years because of your hearing loss. Practice and a positive attitude are important

in learning to use hearing instruments. Your instruments have been adjusted according to your individual

hearing loss and needs. Some people adjust quickly to wearing hearing instruments in their ears and hear-

ing new sounds; other people may need more time.

This product is a custom-made device.

Please read this manual carefully in order to wholly beneﬁt from the use of your hearing instruments. With

proper care, maintenance, and usage, your hearing instruments will aid you in better communication for

many years. Ask your hearing care professional if you have any questions.

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Hearing instrument model:

Model CIC: Battery size 10

Model IIC: Battery size 10

Model ITC: Battery size 13 or 312 (circle one)

Model ITE: Battery size 13 or 312 (circle one)

Model MIH: Battery size 13, 312, or 10 for MIH-S (circle one)

Left serial number:

Right serial number:

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Contents

Statment ... ............................2

Intended use.... .........................3

Prescription use of a Tinnitus Sound

Generator (TSG) hearing instrument.. ........4

Important notice for prospective sound

generator users.........................4

Introduction............................6

Contents ..............................8

Getting started ........................16

On/Off function ........................16

SmartStart ...........................16

Inserting/Replacing the battery............17

Low battery indicator ...................18

Low battery indicator when paired with

wireless accessories only ................18

Inserting/removing hearing instruments .....19

Operation of the hearing instrument . . . . . . . . 22

Volume control (optional).................20

Program button (optional) ................21

Flight mode...........................24

Telephone use.........................25

Telecoil ..............................25

Listen to radio or TV ....................26

Using hearing instruments with smart

phone apps ..........................26

Using hearing instruments with iPhone®,

iPad®, and iPod touch®....................26

Cellular phones .......................27

PhoneNow ...........................27

Tele-loop systems......................29

Care and maintenance ..................29

Daily maintenance......................30

Replacing wax ﬁlters ....................30

General precautions ....................31

General warnings ......................32

Tinnitus Sound Generator (TSG) module ....34

Intended use for the TSG module ..........34

User instructions for the TSG module .......34

Using TSG with smart phone apps .........36

The scientiﬁc concepts that form the basis

for the device .........................36

Technical Speciﬁcations .................37

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TSG warnings .........................38

TSG precautions.......................38

TSG warning to hearing healthcare

professionals..........................39

Battery warning information ..............40

Hearing instrument expectations. ..........41

Warning to hearing aid dispensers .........42

Important notice for prospective

hearing aid users ......................42

Children with hearing loss................43

Troubleshooting guide ..................44

Technical data.........................48

Warranty and repairs....................49

Temperature test, transport and

storage information .....................49

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Mic in Helix (MIH-S) hearing instrument models

with size 10A battery are available in the following

variants:

FL9MIH-S-UP, FL9MIH-S-HP, FL9MIH-S-MP,

FL9MIH-S-LP

Mic in Helix (MIH) hearing instruments

(including type DA312r with FCC ID X26DA312r,

IC number 6941C-DA312r models designated by

a “W”) with size 312 battery and Custom Mic in

Helix hearing instruments (including type DA13r

with FCC ID X26DA13r, IC number 6941C-DA13r

models designated by a “W”) with size 13 battery

are available in the following variants:

FL9MIH-W-UP, FL9MIH-W-HP, FL9MIH-W-MP,

FL9MIH-W-LP, FL9MIH-UP, FL9MIH-HP,

FL9MIH-MP, FL9MIH-LP

FP9MIH-W-UP, FP9MIH-W-HP, FP9MIH-W-MP,

FP9MIH-W-LP, FP9MIH-UP, FP9MIH-HP,

FP9MIH-MP, FP9MIH-LP

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Dieses Handbuch passt für folgende Modelle

137

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