Intended Purpose - Advanced Bionics M Zn-Air CI-5501 Gebrauchsanweisung

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 Zn-Air Battery Pak 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 Zn-Air Battery Pak is intended to power the
Advanced Bionics Naída CI M and Sky CI M Sound Processors.
9