Indications For Use - Advanced Bionics CI-5068 Instrucciones De Uso

INDICATIONS FOR USE

The M Waterproof Battery is an external component of
the HiResolution
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
appropriate auditory milestones (such as spontaneous
response to name in quiet or to environmental sounds)
12
Bionic Ear System, which is intended
TM