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Regulatory information
FDA identifies this generic type of device as:
Self-fitting air-conduction hearing aid.
A self-fitting 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-fitting
strategy and enables users to independently derive and
customize their hearing aid fitting and settings.
