Intended Purpose - Advanced Bionics CI-5607 Instructions D'utilisation

The minimum duration of hearing aid use is waived if
x-rays indicate ossification of the cochlea.
Little or no benefit from appropriately fitted hearing aids.
•
In younger children (< 4 years of age), lack of benefit is
defined as a failure to reach developmentally appropriate
auditory milestones (such as spontaneous response to
name in quiet or to environmental sounds) measured
using the Infant-Toddler Meaningful Auditory Integration
Scale or Meaningful Auditory Integration Scale or ≤ 20%
correct on a simple open-set word recognition test
(Multisyllabic Lexical Neighborhood Test) administered
using monitored live voice (70 dB SPL). In older children
(≥ 4 years of age), lack of hearing aid benefit is defined
as scoring ≤12% on a difficult open-set word recognition
test (Phonetically Balanced-Kindergarten Test) or ≤ 30%
on an open-set sentence test (Hearing In Noise Test for
Children) administered using recorded materials in the
sound field (70 dB SPL).

Intended Purpose

The M Batteries and M Battery Charger are accessories 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
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