Summary Of Relevant Studies - Philips HearLink miniRITE T 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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