Description

In 2017, the United States Congress directed the US Food and Drug Administration (FDA) to develop a new category of hearing aids that could be accessed by the consumer without the engagement of an audiologist or other hearing care provider. The rationale for this expanded category of hearing aids was to address the unmet needs of individuals with perceived mild to moderate hearing loss. Among the stated reasons for the law was that the cost of hearing aids prevents some individuals from seeking treatment for this hearing loss and that access to hearing care can be difficult. 

In response to the law, the American Academy of Audiology developed a guide to assist audiologists in understanding the differences between existing hearing care products and over-the-counter (OTC) devices and was actively involved in providing feedback to the FDA regarding regulations, collaborating with other members of the hearing health community to draft consensus recommendations for this emerging class of devices.

Key Points

The American Academy of Audiology acknowledges consumer autonomy with respect to control over health-care decisions, including access to effective and safe hearing care. It is the position of the Academy that a primary role of audiologists is to optimize hearing health and communication, including the safe and effective use of OTC hearing aids. 

Audiologists should incorporate support of persons who pursue OTC hearing aid technologies, including offering supportive counseling on appropriate care and use, and developing educational and clinical practices to assist consumers in understanding the benefits and risks associated with use of OTC hearing aids. In light of consumers choosing OTC hearing aids, audiologists are encouraged to develop strategies to ensure patient care and safety remain paramount, including objective measurement of hearing aid benefit and functional outcomes.

It is also the position of the Academy that consumers are best served when they receive a comprehensive audiological assessment prior to the use of any hearing aid. Additionally, hearing loss and auditory system deficits are best mitigated through the development of a safe and effective treatment plan that may or may not include OTC hearing aids or other 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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The Audiologist’s Guide to Hearing Aids, Personal Sound Amplification Products, Hearables, and Over-the-Counter Devices

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.

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