Legislation was passed in 2017 requiring the U.S. Food and Drug Administration (FDA) to develop regulations for over-the-counter (OTC) hearing aids. The intent of the legislation was to offer adults with perceived mild-to-moderate hearing loss the opportunity to purchase a device on their own at a lower cost. The regulations were expected to be released in 2020.
OTC Hearing Aids Impact on Audiologists
ASHA believes that patients with hearing loss will continue to need the services of an audiologist. Devices alone do not always meet the rehabilitative needs of people with impaired hearing. Successfully meeting a patient’s communication needs requires an ongoing partnership between the patient and their audiologist. Consumers with OTC hearing aids will need help to address the complexity of their hearing loss and achieve desired outcomes with their devices. The OTC hearing aid bill received significant media attention and raised awareness of the prevalence of hearing loss. Although the legislation was not ideal, many more people are now aware of the audiology profession and the services we can provide.
Learn More About OTC Hearing Aids
- September 23, 2022: FDA OTC Hearing Aid Rule Impact on States
- Over the Counter Hearing Aid ToolKit
- Side-by-Side Comparison of Hearing Care Associations' Recommendations vs. FDA Proposed Rules Released on Oct. 20, 2021 [PDF]
- January 13, 2022: ASHA Submits Comments to FDA on Proposed Rule for a New OTC Hearing Aid Category [PDF]
- October 19, 2021: FDA Releases Proposed Rule for OTC Hearing Aids
- October 13, 2021: Americans Want Professionals’ Guidance on Hearing Care, Know Little About Coming Over-the-Counter Hearing Aids (OTCs); As Federal Regs for the Devices Are Being Prepared, Moving Them Nearer to Market, ASHA/YouGov Poll Reveals Very Limited Public Understanding
- September 16, 2021: ASHA Voices: OTCs on the Horizon
- August 9, 2021: Expected OTC Regulations Offer Messaging Opportunities for Audiologists
- July 9, 2021: Executive Order on Over-the-Counter Hearing Aids Released
- August 2018: ASHA Releases Consensus Paper With Hearing Care Associations
- September 1, 2017: OTC Hearing Aid Legislation Passes, FDA Expected to Develop Regulations
- July 13, 2017: Over-the-Counter Hearing Aid Legislation Passes House, Moves to Senate
- July 1, 2017: Survey Finds Consumers Wary of Over-the-Counter Hearing Aids
- April 30, 2017: House Hearing Tomorrow to Explore Moving Hearing Aids Over the Counter
- April 4, 2017: Hearing Aid Adoption and Satisfaction With the Device Increase with Audiologist Involvement
Contact Bill Knudsen, ASHA's director of education policy, at email@example.com.