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English
FCC ID: QZ3BAHA6MAX
IC: 8039C-BAHA6MAX
HVIN: Baha 6 Max
FVIN: 1.0
PMN: Cochlear Baha 6 Max Sound
Processor
The model is a radio transmitter and
receiver. It is designed not to exceed
the emission limits for exposure to radio
frequency (RF) energy set by the FCC and
ISED. The sound processor is designed not
to exceed the emission limits according to
CAN ICES-003 (B)/NMB-003(B).
The Baha 6 Max sound processor is not
intended to output heat or radiation, and
the Baha 6 Max sound processor does not
produce unwanted outputs of electronic or
magnetic field.
9.2 Certification and
applied standards
The products are in compliance with the
following regulatory requirements:
• In EU: the device conforms to the General
Safety and Performance Requirements
according to Annex I of Medical Device
Regulation 2017/745 (MDR) and essential
requirements and other relevant
provisions of Directive 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.
10. Information
10.1 Service and repair
If your sound processor needs service
repair, please contact your clinic. Contact
details, including an address can be found
on the back cover of this manual.
10.2 Clinical and non-clinical
performance
Bench testing was conducted to compare
the Baha 6 Max Sound Processor with the
Baha 5 Power Sound Processor, including
use with the predicate implant / abutment
systems. Substantial equivalence to
the predicate device was accomplished
through functionality and performance
testing, hardware and interface testing,
reliability and environmental testing, as
well as system and subsystem level testing.
Software verification and validation of
Baha Fitting Software 6 and Baha Smart App
was also completed to establish that the
software are functionally equivalent to their
respective predicate and reference devices
and support substantial equivalence. The
results demonstrated the Baha 6 Max
Sound Processor is functionally equivalent
to the Baha 5 Power Sound Processor.
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