Advanced Bionics M Programming Cable Mode D'emploi page 15

Clinical Benefits
The Clinical Benefit to the patients of the Marvel
accessories is indirect and is related to the HiResolution
Bionic Ear system.
The clinical benefits to the patients of the HiResolution
Bionic Ear system are to:
For adults:
•
- Word recognition score in quiet higher than or
equal to 30% at a minimum of 12 months follow-up
OR improvement higher than 30% compared to
pre-operative stage.
AND/OR
- Sentence recognition score in quiet higher than or
equal to 40% at a minimum of 12 months follow-up
OR improvement higher than 40% compared to
pre-operative stage.
For children:
•
- Before 4 years old: auditory awareness higher
than 50% at a minimum of 12 months follow-up.
- Above 4 years old: word/sentence recognition
in quiet higher than 30% or improvement of 30%
at a minimum of 12 months follow-up.
Users of the M Programming Cable in the
European Union should report any serious
incident to their local competent authority and to
Advanced Bionics.
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