Indications For Use - Advanced Bionics Naída CI M30 Mode D'emploi

The system is designed to provide useful hearing to
individuals with severe-to-profound hearing loss.

INDICATIONS FOR USE

The Naída CI M30 sound processor is an external
component of the HiResolution Bionic Ear System, which
is intended to restore a level of auditory sensation to
individuals with severe-to-profound sensorineural hearing
loss via electrical stimulation of the auditory nerve.
Adults
• 18 years of age or older.
• Severe-to-profound bilateral sensorineural hearing loss
or severe-to-profound unilateral hearing loss.
• Post-lingual onset of severe or profound hearing loss.
• Limited benefit from appropriately fitted hearing aids,
defined as scoring 50% or less on a test of open-set
sentence recognition (HINT Sentences).
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
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