through 5 and 3D Magnet sizes 1 through 4. The Large Color
Cap is for use with the largest Slim HP Magnets: Standard
Magnet sizes 6 and 7 and 3D Magnet sizes 5, 6, and 7.
INDICATIONS FOR USE
The Slim HP, Slim HP Mic, Slim HP AquaMic, and Slim HP
Color Caps are external components 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.
10