Advanced Bionics M Listening Check CI-5827 Bedienungsanleitung

M Listening Check™

CI-5827

instructions for use

English, Français, Español, Deutsch, Nederlands, Italiano

Contents

PURPOSE AND SCOPE OF IFU 5

LIMITATIONS AND CONTRAINDICATIONS 5

PRECAUTIONS, CAUTIONS, AND WARNINGS 5

UNDESIRABLE SIDE EFFECTS 6

PRODUCT DESCRIPTION 6

INDICATIONS FOR USE 7

INTENDED PURPOSE 8

Intended Users 9

Intended Use Environment 10

COMPATIBILITY 10

OPERATING INSTRUCTIONS 10

Listening to the desired input 10

CARE AND MAINTENANCE 16

Storing the M Listening Check 16

Cleaning and Maintenance 16

Recommended Operating, Storage Temperature,

and Humidity Ranges 17

Expected Life 17

Ingress Protection (IP) Ratings 17

DISPOSAL AND HAZARDOUS MATERIALS 17

AVAILABLE PRODUCT OPTIONS AND

MODEL NUMBERS 18

CLINICAL BENEFITS 18

SYMBOLS TABLE

Labeling symbols and their meanings

European Community Mark of Conformity.

Date of Manufacture

Manufacturer

Model number

LOT number

European authorized representative

Unique Device Identiﬁer

MD Medical Device

Suitable temperature range for transport

and storage

See Instructions for Use

Fragile

Do not get wet

XXXX-XX-XX

Suitable relative humidity range for transport

and storage

Caution (refer to “Cautions & Warnings”

section for further information)

Dispose of in accordance with applicable

national and local regulations

MR Unsafe

PURPOSE AND SCOPE OF IFU

This IFU is designed to help cochlear implant recipients,

and their caregivers if applicable, to understand the use

and care of the M Listening Check. It is also meant to be

used by hearing care professionals trained in the ﬁtting of

cochlear implants to counsel the recipients on the use of

the M Listening Check and to troubleshoot problems.

Limitations and Contraindications

As the M Listening Check is a component of the HiResolutionTM

Bionic Ear System, the following contraindications stated

for the HiResolution Bionic Ear System are applicable:

Deafness due to lesions of the acoustic nerve or central

auditory pathway; cochlear ossiﬁcation that prevents electrode

insertion; absence of cochlear development.

Precautions, Cautions, and Warnings

• CHOKING HAZARD: Contains small parts that pose

a hazard of inhalation, choking, or ingestion. If any

parts are swallowed or inhaled, consult a physician or

hospital immediately.

• Do not leave children unattended with or allow children

to play with the M Listening Check.

• Do not allow children to place the M Listening Check

in the mouth.

• Do not attempt to service or modify the Naída CI M,

SkyCI M, or its accessories. Doing so may compromise

system performance and will void the manufacturer’s

warranty. Products should be serviced only at

Advanced Bionics and damaged products should

bereturned to Advanced Bionics.

Undesirable Side Effects

Undesirable side eects of your Naída CI M or Sky CI

Msystem may include skin irritation and discomfort from

pressure on the ear, device overheating, or overly loud

sounds.

Product Description

The M Listening Check is an accessory for the Naída CI

M and Sky CI M Sound Processors to allow someone the

ability to listen to the Advanced Bionics Naída CI M and

Sky CI M Sound Processor input sound sources via the

MListening Check Earbuds.

M Listening Check

Sound Processor

Connector

Battery Connector

Auxiliary Jack

INDICATIONS FOR USE

The M Listening Check is an external component of

theHiResolution Bionic Ear System, which is intended

to restore a level of auditory sensation to individuals

with severe-to-profound sensorineural hearing loss via

electrical stimulation of the auditory nerve.

Adults

• 18 years of age or older.

• Severe-to-profound bilateral sensorineural hearing

lossor severe-to-profound unilateral hearing loss.

• Post-lingual onset of severe or profound hearing loss.

• Limited beneﬁt from appropriately ﬁtted hearing aids,

deﬁned as scoring 50% or less on a test of open-set

sentence recognition (HINT Sentences).

Children

• 12 months through 17 years of age.

• Severe-to-profound bilateral sensorineural deafness or

severe-to-profound unilateral hearing loss.

• Use of appropriately ﬁtted hearing aids for at least

6months in children 2 through 17 years of age, or at

least 3 months in children 12 through 23 months of age.

The minimum duration of hearing aid use is waived if

x-rays indicate ossiﬁcation of the cochlea.

• Little or no beneﬁt from appropriately ﬁtted hearing aids.

In younger children (< 4 years of age), lack of beneﬁt is

deﬁned as a failure to reach developmentally appropri-

ate auditory milestones (such as spontaneous response

to name in quiet or to environmental sounds) measured

using the Infant-Toddler Meaningful Auditory Integration

Scale or Meaningful Auditory Integration Scale or

≤20% correct on a simple open-set word recognition

test (Multisyllabic Lexical Neighborhood Test) adminis-

tered using monitored live voice (70 dB SPL). In older

children (≥ 4 years of age), lack of hearing aid beneﬁt

is deﬁned as scoring ≤12% on a dicult open-set word

recognition test (Phonetically Balanced-Kindergarten

Test) or ≤ 30% on an open-set sentence test (Hearing

In Noise Test for Children) administered using recorded

materials in the sound ﬁeld (70 dB SPL).

Intended Purpose

The M Listening Check is an accessory of an auditory active-

implantable system, the HiResolution Bionic Ear system.

The HiResolution Bionic Ear system is intended to provide

auditory sensation via electrical stimulation of the auditory

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