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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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