The Audiologist’s Guide to Hearing Aids, PSAPs, Hearables, and OTC Devices

The Food and Drug Administration (FDA) is developing proposed regulations for over-the-counter (OTC) hearing aid devices. According to the FDA Reauthorization Act of 2017, these devices will be available to the consumer through retail outlets and without having to engage an audiologist, either for a pre- purchase hearing evaluation, or for the selection, fitting or verification of performance of the device.

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