Summary Of Relevant Studies - oticon Intent 1 miniRITE 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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