Advanced Bionics M Programming Cable Mode D'emploi page 10

• Little or no benefit from appropriately fitted hearing
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
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