Summary Of Safety And Clinical Performance; Guidelines For It Security; Intended Use Environment - Advanced Bionics Naída CI M90 Instrucciones De Uso

Note: In the United States, Fixed Directional mode,
StereoZoom, UltraZoom, Sound Relax, NoiseBlock,
WindBlock, and EchoBlock are approved for use
in pediatric recipients 6 years and above who are
1) able to complete objective speech perception
testing in order to determine speech performance
and 2) able to report a preference for different coding
strategies or features.
SUMMARY OF SAFETY AND CLINICAL
PERFORMANCE
A summary of safety and clinical performance (SSCP)
is available in the European database on medical
devices (Eudamed), where it is linked to the Basic
UDI-DI:- 08400944CI5293YE
https://ec.europa.eu/tools/eudamed
Users of the Naída CI M90 sound processor
in the European Union should report any serious
incident to their local competent authority and
to Advanced Bionics.

GUIDELINES FOR IT SECURITY

Intended Use Environment

The Naída CI M90 sound processor system is intended
for use in healthcare and home environments. The
home environment is extended to include use outdoors
and during travel (e.g., airplanes). The Naída CI M90
sound processor system is intended to operate with the
AB Remote application, the Phonak RemoteControl, the
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