Summary Of Safety And Clinical Performance - Advanced Bionics Naída CI M30 Manual De Usuario

Cautions
• UltraZoom is a beamforming algorithm; therefore,
by design it focuses to the front and dampens sound
from the side and back of the recipient.
• The Naída CI sound processor is designed so it can
be worn in an off-ear wearing configuration. We do
not recommend the processor be worn in the off-ear
wearing configuration while using any beamforming
algorithm.
Note: In the United States, UltraZoom is 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:
- 08400944CI5294YG
https://ec.europa.eu/tools/eudamed
Users of the Naída CI M30 sound processor in
the European Union should report any serious
incident to their local competent authority and to
Advanced Bionics.
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