Scope And Purpose Of This Ifu; Indications For Use - Advanced Bionics CI-6058-001 Instrucciones De Uso

Scope and Purpose of this IFU

This IFU is designed to help cochlear implant recipients,
and their caregivers if applicable, to appropriately use
the AB Remote software. It is also meant to be used
by hearing care professionals trained in the fitting of
cochlear implants to counsel the recipients on the use of
the AB Remote software.

Indications for Use

The AB Remote software is a 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.
4
Bionic Ear System, which is intended
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