Advanced Bionics CI-7322, Instructions For Use Manual

Page: 11 / 120

9
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 Wearing Clip, M Snuggie, and M Retention Cuff
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 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.