Purpose And Scope Of Ifu; Limitations And Contraindications; Precautions, Cautions, And Warnings - Advanced Bionics M T-Mic Instrucciones De Uso

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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