Clinical Benefits; Summary Of Safety And Clinical Performance - Advanced Bionics Slim HP Instrucciones De Uso

CLINICAL BENEFITS

The Intended Clinical Benefit of the Slim HP, Slim HP Mic,
Slim HP AquaMic, and Slim HP Color Caps as parts of
the HiResolution Bionic Ear System is to:
provide useful hearing to individuals with severe-to-
•
profound hearing loss via electrical stimulation of the
auditory nerve.
• provide a combined type of stimulation, electric plus
acoustic, when sound processors are enabled with
the Acoustic Earhook.
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:- Slim HP - 08400944CI5320XQ, Slim
HP AquaMic - 08400944CI5321XS,
Slim HP Mic - 08400944CI5322XU
https://ec.europa.eu/tools/eudamed
Users of the Slim HPs in the European Union should
report any serious incident to their local competent
authority and to Advanced Bionics.
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