The path to over-the-counter (OTC) hearing aids has been a long and carefully regulated journey. Recently, Thomas A. Powers, PhD, presented on Audiology Online about the history, legislation, and key drivers that led to their introduction. Below is a detailed summary of that pathway — from early policy discussions to full market availability in 2022.
Perceptions that Drove the Creation of OTC Hearing Aids
One of the strongest motivators behind the FDA’s creation of the OTC hearing aid category was cost. Hearing aids have historically been expensive, especially when bundled with professional services. Early meetings involving PCAST (President’s Council of Advisors on Science and Technology), NASM (National Academy of Sciences, Engineering, and Medicine), FDA, and FTC also discussed the issue of limited access to professionals.
Additionally, research increasingly linked untreated hearing loss to cognitive decline, dementia, and Alzheimer’s disease. Hearing loss is one of the few modifiable risk factors for dementia, generating public health interest — but also leading to misconceptions and oversimplifications in the marketplace.
The Lack of Medicare Coverage
Since its inception in 1965, Medicare has excluded hearing aids and related services from coverage — along with most dental and vision care. At the time, there was limited understanding of how hearing aids improved communication, relationships, and quality of life.
Today, coverage remains limited to certain medically necessary devices like cochlear implants or bone-anchored hearing aids for qualifying individuals. As a result, cost remains one of the largest barriers to hearing aid adoption. However, some Medicare Advantage plans now offer partial hearing benefits, along with dental and vision coverage, to attract enrollees seeking care options not available under Original Medicare.
The Timeline for OTC Hearing Aids
The OTC hearing aid initiative began taking shape after a 2009 NIH meeting highlighting access and affordability issues. Over the next decade, workshops and policy discussions by PCAST, the National Academies, FDA, and FTC shaped recommendations for a new regulatory category.
Key milestones:
- 2009 – NIH meeting identifies affordability and access concerns.
- 2015–2016 – PCAST and NASM recommend an OTC category.
- August 2017 – Congress passes OTC Hearing Aid legislation.
- August 2022 – FDA publishes final rule.
- October 17, 2022 – OTC hearing aids officially become available to the public.
Compliance Dates for Manufacturers
The FDA’s final rule established separate compliance timelines for existing and new products:
- New products (not legally marketed before October 17, 2022) – Required to submit new 510(k) clearance before launch.
- Existing products (already FDA-cleared) – Had until April 2023 to meet the new labeling and performance requirements.
These compliance rules ensure that both long-established hearing aid companies and new OTC entrants meet safety, labeling, and performance standards before reaching consumers.
What This Means for Consumers
OTC hearing aids increase accessibility and affordability for adults with perceived mild-to-moderate hearing loss. However, they are not a replacement for professional care in cases of severe hearing loss, sudden changes in hearing, or medically complex situations.
For more on how OTC devices compare to prescription hearing aids, see our in-depth guide: OTC vs Traditional Hearing Aids: Cost, Fit, and Performance.