Intended Purpose - Advanced Bionics Naída CI M30 Mode D'emploi

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 Naída CI M30 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 Naída CI M30 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
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