Intended Purpose; Intended Use; Intended Users - Advanced Bionics Sky CI M90 CI-5295 Instrucciones De Uso

Intended Purpose

The Sky CI M90 sound processor is an accessory 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 Sky CI M90 sound processor is a behind-
the-ear (BTE) sound processor which works together with
the implant to bypass the damaged part of the inner ear and
converts 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 Sky CI M90 sound processor can be used by both
adults and children, and provides dedicated pediatric
hearing solution (multiple color options, and adjustable
program for individual pediatric users). The Sky CI M90
provides full access to multiple automatic programs and
features including bimodal and bilateral and supports
compatibility with acoustic amplification.

Intended Users

The intended users of the Sky CI M90 sound processor are
recipients of Advanced Bionics cochlear implants, 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,
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