Intended Purpose; Intended Users - Advanced Bionics M CI-5851 Bedienungsanleitung

Intended Purpose

The M Acoustic Earhook is an external component of
an auditory active implantable system, the HiResolution
Bionic Ear system. The HiResolution Bionic Ear system
is intended to provide auditory sensation via electrical
stimulation of the auditory nerve for individuals with severe
to profound bilateral or unilateral sensorineural hearing
loss. Severe hearing loss is defined as audiometric
thresholds greater than or equal to 70 dB HL, but less than
90 dB HL. Profound hearing loss is defined as audiometric
thresholds greater than or equal to 90 dB HL. The external
components work together with the implant to bypass
the damaged part of the inner ear and 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. The M Acoustic
Earhook provides acoustic amplification for patients with
aidable low frequency hearing.
The M Acoustic Earhook coupled with the Naída CI M90
or Sky CI M90 sound processor is intended to provide
acoustic amplification and electrical stimulation to
Advance Bionics cochlear implant recipients.

Intended Users

The intended users of the M Acoustic Earhook are recipients
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
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