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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 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.
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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