Summary Of Relevant Studies - oticon BTE SP Instructions For Use Manual

Summary of relevant studies

Clinical evaluations conducted by or
for the manufacturer provide evidence
to support the intended use and
clinical benefits 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 sufficient audibility and hearing
loss compensation based on best-
practice prescriptive fitting rationales.
The clinical data also demonstrate
improved speech understanding and
success with hearing aids using validated
questionnaires and surveys.
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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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