Cochlear Baha 5 User Manual page 15

Intended use
The Cochlear™ Baha
uses bone conduction to transmit
sounds to the cochlea (inner ear). It is
indicated for people with conductive
hearing loss, mixed hearing loss and
single sided sensorineural deafness (SSD).
Furthermore it is indicated for bilateral
and paediatric recipients. Fitting range
up to 45 dB SNHL. It works by combining
a sound processor and a small titanium
implant that is placed in the skull behind
the ear. The skull bone integrates with the
titanium implant through a process called
osseointegration. This allows sound to
be conducted via the skull bone directly
to the cochlea, which improves hearing
performance. The sound processor can
be used together with the Baha Softband.
The fitting is to be done either at a
hospital, by an audiologist, or in some
countries, by a hearing care professional.
List of countries:
Not all products are available in all
markets. Product availability is subject
to regulatory approval in the respective
markets.
The products are in compliance with the
following regulatory requirements:
• In EU: the device conforms to the
Essential Requirements according to
Annex I of Council Directive 93/42/
EEC for medical devices (MDD) and
essential requirements and other
relevant provisions of Directive
5 Sound Processor
®
2014/53/EU (RED). The declaration of
conformity may be consulted at
www.cochlear.com.
• Other identified applicable
international regulatory requirements
in countries outside the EU and
US. Please refer to local country
requirements for these areas.
• In Canada the sound processor
is certified under the following
certification number: IC: 8039C-BAHA5
and model no.: IC model: Baha
• This device complies with Industry
Canada licence-exempt RSS
standard(s).
• This Class B digital apparatus
complies with Canadian ICES-003. Cet
appareil numérique de la classe B est
conforme à la norme NMB-003 du
Canada.
• Operation is subject to the following
two conditions: (1) this device may
not cause interference, and (2) this
device must accept any interference,
including interference that may cause
undesired operation of the device.
L' e xploitation est autorisée aux deux
conditions suivantes : (1) l'appareil ne
doit pas produire de brouillage, et (2)
l'utilisateur de l'appareil doit accepter
tout brouillage radioélectrique subi,
même si le brouillage est susceptible
d' e n compromettre le fonctionnement.
English
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