Intended Purpose - Advanced Bionics M Listening Check CI-5827 Instrucciones De Uso

Children
• 12 months through 17 years of age.
Severe-to-profound bilateral sensorineural deafness or
•
severe-to-profound unilateral hearing loss.
Use of appropriately fitted hearing aids for at least
•
6 months in children 2 through 17 years of age, or at
least 3 months in children 12 through 23 months of age.
The minimum duration of hearing aid use is waived if
x-rays indicate ossification of the cochlea.
• 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 appropri-
ate 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) adminis-
tered 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 Listening Check 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
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