This guidance was developed to assist audiologists in understanding the differences between prescription hearing aids and over-the-counter (OTC) hearing aids and in answering questions about these devices and to guide the evolution of clinical practices in light of the availability of OTC hearing aids.

Key Points

The Food and Drug Administration (FDA) published final rules for OTC hearing aid devices on August 17, 2022. Under the FDA Reauthorization Act of 2017 and FDA regulatory statutes, these devices are to be available to the consumer through retail outlets and without having to engage an audiologist, either for a prepurchase hearing evaluation or for the selection, fitting, or verification of performance of the device.

This document reviews devices and technologies currently available for consumers and patients. The options presented within this document do not include surgically implantable devices (e.g., cochlear implants, middle ear implants, etc.). The Academy believes that it is in the best interest of any patient considering amplification to have a comprehensive hearing evaluation by an audiologist prior to making decisions regarding hearing devices. In this manner, consumers can be informed as to their needs and possible solutions.

Get Involved

Whether serving on a clinical document development panel or participating as peer reviewers, volunteers have regular chances to deepen their engagement with the Academy and make important contributions benefiting the field of audiology. If you are interested in clinical document development, please volunteer to express interest and submit a CV to the Academy’s guidelines staff by email. To view the list of guidelines and strategic documents in development and to learn more about the Academy’s clinical document development process, visit the Academy’s Practice Resources website. Information from interested members is accepted on an ongoing basis, and members will be contacted as clinical document volunteer openings occur.
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