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.
While OTC devices have not yet entered the marketplace, the Academy has developed this guide to assist audiologists in understanding the differences between existing products and OTC devices, to be ready to answer questions about these devices, and possibly to begin to pre-position practices in anticipation of the availability of OTC devices. This guidance will be updated as the regulations for OTC devices become available.