Purpose And Scope Of Ifu; Limitations And Contraindications; Precautions, Cautions, And Warnings - Advanced Bionics M T-Mic CI-5837 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 T-Mic and M Earhooks. It is also meant to
be used by hearing care professionals trained in the fitting
of cochlear implants to counsel recipients on the use of
the M T-Mic and M Earhooks and to troubleshoot problems.

Limitations and Contraindications

As the M T-Mic and M Earhooks are 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 T-Mic or M Earhook.
• Do not allow children to place the M T-Mic or
M Earhook in the mouth.
Bionic Ear System, the following
TM
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