Indications For Use - Advanced Bionics CI-7322 Manuel D'instructions

INDICATIONS FOR USE

The M Wearing Clip, M Snuggie, and M Retention Cuff
are 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
benefit is defined as a failure to reach developmentally
8
TM