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Hearables

Hearables

FDA Approves Marketing of First Self-Fitting Hearing Aid

The Academy has just become aware of the FDA’s approval of marketing of first self-fitting hearing aid and is identifying any necessary steps to protect the community of consumers who are hard of hearing.

We are closely monitoring and asking our members and the state organizations to be watchful of appropriate process in the distribution. 

As stated by the FDA: “…the device must comply with applicable federal and state laws regarding the sale of hearing aids, including state laws that might require hearing aids….”

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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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