Cochlear Baha 5 User Manual page 14

NOTE:
This equipment has been tested
and found to comply with the
limits for a Class B digital device,
pursuant to part 15 of the FCC
Rules. These limits are designed
to provide reasonable protection
against harmful interference in
a residential installation. This
equipment generates, uses and
can radiate radio frequency energy
and, if not installed and used in
accordance with the instructions, may
cause harmful interference to radio
communications. However, there is
no guarantee that interference will
not occur in a particular installation.
If this equipment does cause harmful
interference to radio or television
reception, which can be determined
by turning the equipment off and
on, the user is encouraged to try to
correct the interference by one or
more of the following measures:
• Reorient or relocate the receiving
antenna.
• Increase the separation between
the equipment and receiver.
• Connect the equipment into an
outlet on a circuit different from
the one in which the receiver is
connected.
• Consult the dealer or an
experienced radio/TV technician
for help.
• Changes or modifications can void
the user's authority to operate the
equipment.
14
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
®