Advanced Bionics CI-5551 - Intended Users; Intended Use Environment

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convert sound picked up by the microphone or streamed via
wireless communication into electrical signals that are used
by the cochlear implant to enable hearing.
M Batteries are intended to power the AdvancedBionics
NaídaCIM and Sky CI M Sound Processors. The
MBattery Charger is intended to recharge only the
MBatteries. Placing acharged M Battery on the sound
processor will poweronthe sound processor. Removing
the M Battery will power o the sound processor.
Intended Users
The intended users of the M Batteries and M Battery Charger
are users of the Naída CI M or Sky CI M Sound Processors,
their caregivers if applicable, and hearing care professionals.
The recipient, or their caregiver, should, at a minimum,
becapable of changing the battery, connecting the earhook,
placing and removing the sound processor from their ear, and
placing and removing the headpiece from the implant site.
The hearing care professional should be trained in the use
and fitting of the cochlear implant system.
Intended Use Environment
The intended use environments of the M Batteries and M
Battery Charger are healthcare and daily living environments.
The M Batteries are designed to be worn daily during
the user’s normal waking hours. There is no minimum or
maximum duration of use for the M Battery Charger.