Clinical Benefits; Summary Of Safety And Clinical Performance - Advanced Bionics CI-5851-001 Mode D'emploi

P
roduCt
o
Ption
Right, Size 3
Earhook Pin
(10-pack)

CLINICAL BENEFITS

The Intended Clinical Benefit of the M Acoustic Earhook as
part 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:- 08400944CI5851YU
https://ec.europa.eu/tools/eudamed
Users of the M Acoustic Earhook in the European
Union should report any serious incident to their
local competent authority and to Advanced Bionics.
M
odel
n
uMber
CI-5851-005
CI-6147-015
P
roduCt
o
Ption
Left, Size 3
Pin Removal
Tool (2-pack)
M
odel
n
uMber
CI-5851-010
CI-6147-014
25