Advanced Bionics CI-5851 Manuel utilisateur

M ACOUSTIC EARHOOK

CI-5851

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 7

PRODUCT DESCRIPTION 7

INDICATIONS FOR USE 8

INTENDED PURPOSE 10

Intended Users 10

Intended Use Environment 11

COMPATIBILITY 11

OPERATING INSTRUCTIONS 11

Removing and Attaching the Dome 12

Exchanging the Earwax Protection 13

Connecting the M Acoustic Earhook 16

Removing the M Acoustic Earhook 18

Inserting and Removing the

M Acoustic Earhook onthe Ear 21

CARE AND MAINTENANCE 22

Storing the M Acoustic Earhook 22

Cleaning and Maintenance 22

Recommended Operating, Storage Temperature,

and Humidity Ranges 23

Expected Life 24

Ingress Protection (IP) Ratings 24

DISPOSAL AND HAZARDOUS MATERIALS 24

AVAILABLE PRODUCT OPTIONS AND MODEL

NUMBERS 24

CLINICAL BENEFITS 25

SUMMARY OF SAFETY AND CLINICAL

PERFORMANCE 25

SYMBOLS TABLE

Labeling symbols and their meanings

European Community Mark of Conformity.

Authorized to ax the CE Mark in 2021

Date of Manufacture

Manufacturer

Model number

LOT number

European authorized representative

Unique Device Identiﬁer

MD Medical Device

Type of Protection: BF

Suitable temperature range for transport

and storage

See Instructions for Use

Fragile

XXXX-XX-XX

Do not get wet

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 Acoustic Earhook. 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 Acoustic Earhook.

Limitations and Contraindications

As the M Acoustic Earhook is a component of the

HiResolution™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

• This device should be used only by the individual for

whom it is prescribed.

• 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 Acoustic Earhook.

• Do not allow children to place the M Acoustic Earhook

in the mouth.

• The M Acoustic Earhook should only be used by the

intended recipient and not by any other individual.

• Exposure of the M Acoustic Earhook to high humidity,

sweat, or water could damage the speaker unit.

• Placing the M Acoustic Earhook within close proximity

to the headpiece magnet may damage the M Acoustic

Earhook.

• Remove your sound processor and consult your

cochlear implant professional if uncomfortable sounds

are heard or in case of discomfort, pain or skin irritation.

• Do not use the M Acoustic Earhook unless the earwax

protection is properly seated and the appropriate dome

is attached.

• In the unlikely event that the dome or earwax protection

becomes dislodged in the ear canal, contact your

cochlear implant professional. Do not try to remove the

dome or earwax protection from your ear canal yourself.

• If you observe any changes in sound quality with the M

Acoustic Earhook, please contact Advanced Bionics or

your cochlear implant professional.

• In the event that you experience any issues with

your product, please contact your cochlear implant

professional or the manufacturer. Do not attempt to

service or modify the Naída CI 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 Acoustic Earhook is an attachment to the

AdvancedBionics Naída™ CI M90 and Sky CI™ M90

sound processors. The M Acoustic Earhook allows for the

addition of acoustic ampliﬁcation to the electrical stimulation

traditionally produced by a cochlear implant. From the sound

processor connector, a cable extends to the speaker unit that

transfers sound inputs through the sound outlet into the ear

canal. There are 5 sizes of the M Acoustic Earhook for right

and left ears to accommodate dierent ear sizes and shapes.

Domes attach to the speaker unit of the acoustic earhook to

provide a comfortable ﬁt in the ear canal.

Sound

Processor

Connector

Speaker

Power DomeVented Dome

The connector pins and pin removal tool are also included.

Conector Pin

Pin Removal

Tool

INDICATIONS FOR USE

The M Acoustic Earhook 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.

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