Over-the-Counter Hearing Aids
CTA, member companies and allied organizations have continued to advance the OTC hearing aid category since the FDA's final rule in 2022. This page is a culmination of previous and ongoing efforts to activate this category and advance access, awareness, and adoption.
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Over-the-Counter (OTC) Hearing Aid Timeline
The Food and Drug Administration’s (FDA) final rule authorizing over-the-counter (OTC) hearing aids is the culmination of years-long advocacy by CTA, member companies and allied organizations.
Beginning in mid-October 2022, Americans with mild to moderate hearing loss have had access to affordable hearing aids from a local store or online.
What the Hearing Health Community Is Saying
Advocates, clinicians and innovators share their perspectives on the OTC hearing aid category.
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Lindsay Creed, American Speech-Language-Hearing Association
"From our perspective, OTC hearing aids have expanded the range of options available to adults with perceived mild to moderate hearing loss, while also reinforcing the importance of consumer education and access to audiologists for diagnosis, counseling and ongoing hearing health care."
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Andrew Bellavia, AuraFuturity
"Innovations and alternative form factors in the OTC space have created positive impressions of their appearance and decreased stigma, with the further benefit of reducing resistance to seeking professional care when indicated."
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Bruce Borenstein, Opn Sound
"The introduction of the OTC hearing aid category has been an important step forward in making hearing care more accessible, affordable and consumer-friendly."
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Douglas L. Beck, EssilorLuxottica
"OTC hearing aids continue to evolve and impact and alter the hearing aid landscape. [...] OTC will continue to improve (just like prescription products) and the outlook for these ever-improving products is excellent."
Relevant Standards
Gary Shapiro, Executive Chair, CTAOver-the-counter hearing aids will benefit tens of millions of Americans, reducing the cost, social isolation and stigma experienced by many people with mild to moderate hearing loss.
Featured Resource
OTC Hearing Aids: What You Should Know (FDA)
This resource from the FDA outlines what you should know before and after purchasing an OTC hearing aid.