Intended Purpose - Advanced Bionics Naída CI M90 Instrucciones De Uso

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 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 M90 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
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