Purpose And Scope Of Ifu; Limitations And Contraindications; Precautions, Cautions, And Warnings - Advanced Bionics CI-5851-001 Mode D'emploi

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
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.
Bionic Ear System, the following
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