Intended Purpose; Intended Users - Advanced Bionics HP Standard Instrucciones De Uso

lack of hearing aid benefit is defined as scoring
≤12% on a difficult open-set word recognition test
(Phonetically Balanced-Kindergarten Test) or ≤ 30%
on an open-set sentence test (Hearing In Noise Test
for Children) administered using recorded materials
in the sound field (70 dB SPL).

Intended Purpose

The Slim Headpiece Magnets are accessories 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 to bypass the damaged part of the inner ear and
convert sound picked up by the microphone or streamed
via wireless communication into electrical signals that are
used by the cochlear implant to enable hearing.
The Slim HP Magnets are intended to be used with the
Slim HP, Slim HP Mic, Slim HP AquaMic™ microphone,
and Slim HP Standard. The Slim HP Magnets are intended
to secure the headpiece to the user's head.

Intended Users

The intended users of the Slim HP magnets are recipients
of the Slim HP products.
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