Intended Purpose - Advanced Bionics M T-Mic 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 M T-Mic and M Earhooks 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
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