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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
regulatory conformity. Clinical data is
collected, assessed, and analyzed to support
the performance of the hearing aids by
audibility and hearing loss compensation
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
evaluation, electromagnetic compatibility
(EMC) evaluation, and documentation of
radio properties and performance. Additional
information can be found in section Technical
Information.