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About Start-up Handling Options Tinnitus Warnings More info
Summary of relevant studies
Clinical evaluations conducted by or
for the manufacturer provide evidence
to support the intended use and
clinical benets outlined in the IFU and
demonstrate regulatory conformity.
Clinical data is collected, assessed, and
analyzed to support the performance of
the hearing aids by validating that they
provide sucient audibility and hearing
loss compensation based on best-practice
prescriptive tting rationales. The clinical
data also demonstrate improved speech
understanding and success with hearing
aids using validated questionnaires and
surveys.
Non-clinical data supporting the overall
performance of the hearing aids includes
software verification, electroacoustic
verification, electrical and mechanical
safety evaluation, electromagnetic
compatibility (EMC) evaluation, and
documentation of radio properties and
performance. Additional information can
be found in section Technical Information.
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