Intended use – Indications – Contraindications
8
Intended use
The SONNET 2 audio processor is an external part of the MED‑EL Cochlear Implant
System. The MED‑EL Cochlear Implant System is intended to evoke auditory sensation
via electrical stimulation of the auditory pathways for severely to profoundly hearing
impaired individuals who obtain little or no benefit from acoustic amplification in the
best aided condition.
Additionally, the MED‑EL Cochlear Implant System used in combination with the
FLEX
24
(2)
or FLEX
20
electrode is intended to evoke auditory sensations via electrical
stimulation or via combined electric‑acoustic stimulation (EAS) of the auditory pathways
for partially deaf individuals, who obtain benefit from acoustic amplification in the
lower frequencies only.
The MED‑EL Cochlear Implant System is also intended to evoke auditory sensations
via electrical stimulation of the auditory pathways for individuals with single‑sided
deafness, which is defined as severe to profound hearing impairment in one ear and
normal hearing or mild to moderate hearing impairment in the other ear.
The Auditory Brainstem Implant (ABI) is used for electrical stimulation of the cochlear
nucleus (CN) via an implanted stimulator and a specially designed electrode array to
evoke auditory sensations in patients with non‑functional cochlear nerves.
2 The FLEX
24
electrode was formerly marketed as the FLEX
EAS
electrode. Implementation of the FLEX
EAS
name
change to FLEX
24
may depend on regulatory approval and the electrode may therefore still be marketed as
FLEX
EAS
in some markets.
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Страница 9: ...7 Intended use Indications Contraindications CHAPTER 3...
Страница 13: ...11 SONNET 2 audio processor CHAPTER 4...
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Страница 49: ...47 CHAPTER 5 Special considerations for young children...
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Страница 100: ...MED EL Elektromedizinische Ger te GmbH F rstenweg 77a 6020 Innsbruck Austria office medel com medel com...