Regulatory Information - Sony CRE-C10 Safety And Maintenance Instructions

H ODWR IR DW R
FDA identi es this generic type of device as:
Self- tting air-conduction hearing aid.
A self- tting air-conduction hearing aid is a wearable
sound amplifying device that is intended to compensate for
impaired hearing and incorporates technology, including
software, that allows users to program their hearing aids.
This technology integrates user input with a self- tting
rategy and enables users to independently derive and
cu omize their hearing aid tting and settings.
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