Intended Purpose - Advanced Bionics Slim HP Série Mode D'emploi

Little or no benefit from appropriately fitted hearing aids.
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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 Slim HP headpieces are part of the external components
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.
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