Although over-the-counter (OTC) devices have not yet entered the marketplace, this guidance was developed 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 preposition practices in anticipation of the availability of OTC devices. This guidance will be updated as the final regulations for OTC devices become available.

Key Points

The Food and Drug Administration (FDA) published proposed rules for OTC hearing aid devices on October 20, 2021. The comment period ended on January 18, 2022, and final rules are expected later in 2022. 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 prepurchase hearing evaluation or for the selection, fitting, or verification of performance of the device. 

The Academy developed and submitted several statements to Congress and the FDA to assist in their deliberations regarding OTC devices. The first statement (Appendix 1) addressed accessibility to hearing care, assessment and identification of hearing loss, management of hearing loss, affordability of hearing care technology and services, and education for the consumer. Subsequent to the signing of the FDA Reauthorization Act, the Academy also submitted additional recommendations to the FDA for consideration during the rulemaking process (Appendix 2). These recommendations were targeted on specific technological or labeling requirements for OTC devices.

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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