Indications For Use - Advanced Bionics M Zn-Air CI-5501 Gebrauchsanweisung

INDICATIONS FOR USE

The M Zn-Air Battery Pak 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) measured
8
Bionic Ear System, which is intended
TM