Undesirable Side Effects; Product Description And Performance Characteristics; Intended Purpose - Advanced Bionics CI-6058-001 Instrucciones De Uso

UNDESIRABLE SIDE EFFECTS

Undesirable side effects of using the app may include:
- adjusting volume levels to a loudness that
is uncomfortable
- selecting a program that is inappropriate for
the current listening environment
PRODUCT DESCRIPTION AND
PERFORMANCE CHARACTERISTICS
The AB Remote is a smartphone app that is designed to
provide user control over volume and program changes as
well as provide access to help information.
The AB Remote app provides direct connectivity and
control of Advanced Bionics Naída CI M and Sky CI M
sound processors and Phonak Naída Link M and
Sky Link M hearing instruments.

INTENDED PURPOSE

The AB Remote app is an accessory of an auditory active
implantable system, the HiResolution Bionic Ear system.
The HiResolution Bionic Ear system is intended to provide
auditory sensation via electrical stimulation of the auditory
nerve for individuals with severe to profound bilateral or
unilateral sensorineural hearing loss. Severe hearing loss
is defined as audiometric thresholds greater than or equal
to 70 dB HL, but less than 90 dB HL. Profound hearing loss
is defined as audiometric thresholds greater than or equal to
90 dB HL. The external components work together with the
implant of the HiResolution Bionic Ear system to bypass the
damaged part of the inner ear and convert sound picked up
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