Intended Purpose - Advanced Bionics CI-5826 Manual Del Usuario

Little or no benefit from appropriately fitted hearing
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aids. 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 M Programming Cable 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
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