Intended Purpose - Advanced Bionics CI-5068 Anleitung

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 Waterproof Battery 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 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 Waterproof Battery is intended to power the
Advanced Bionics Naída CI M and Sky CI M Sound
Processors and protect the sound processor for moisture
and debris. Connecting the sound processor to the
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