Cochlear Baha 5 Manual Del Usuario página 10

Intended use
The Cochlear Baha System uses bone
conduction to transmit sounds to the
cochlea (inner ear) with the purpose of
enhancing hearing. The Baha 5 Power
Sound Processor is intended to be used
as part of the Cochlear Baha System to
pick up surrounding sound and transfer
it to the skull bone via a Baha Implant,
Baha Softband or Baha SoundArc and can
be used unilaterally or bilaterally.
Indications
The Baha System is indicated for
patients with conductive hearing loss,
mixed hearing loss and single-sided
sensorineural deafness (SSD). The
Baha 5 Power Sound Processor is
indicated for patients with up to 55 dB
SNHL.
Clinical benefit
Most recipients of a bone conduction
hearing solution will experience improved
hearing performance and quality of life
compared to unaided listening.
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.
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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
2014/53/EU (RED).
• 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-BAHA5POWER
and model no.:
IC model: Baha 5 Power.
®
• 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.
Equipment includes RF transmitter.
NOTE:
The sound processor is suited for use
in a home healthcare environment.
The home healthcare environment
includes locations such as homes,
schools, churches, restaurants,
hotels, cars, and airplanes, where
equipment and systems are less likely
to be administered by healthcare
professionals.
English
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