Over-the-Counter Hearing Aids



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.



Featured Standard

Four Frequency Pure Tone Average Testing Methodology and Reporting Metrics for Consumer Facing Hearing Solutions (ANSI/CTA-2118)

This document identifies the elements of a standard testing methodology for a consumer-facing hearing metric and establishes common terminology to describe hearing wellness throughout a consumer’s lifetime.


Relevant Standards:

Wearable Sound Amplifier Performance Criteria (ANSI/CTA-2051-A)
Personal Sound Amplification Performance Criteria (ANSI/CTA-2051)
Over-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.
Gary Shapiro, President and CEO, CTA


Featured Videos

The New World of Over-the-Counter Hearing Aids This CES session explores how industry efforts will improve the lives of millions and how this can serve as a model for future health tech products.

Dr. Frank Lin Discusses OTC Hearing Aids  We sat down with Dr. Frank Lin, Director, Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health, to discuss the importance of over-the-counter (OTC) hearing aids.

OTC Hearing Aids One Year Anniversary Congressman Buddy Carter delivers remarks to recognize the one-year anniversary of over-the-counter hearing aids.

Interview with John Luna on OTC Hearing Aids  John Luna, CEO of Sound Business Consulting, discusses the importance of OTC hearing aids.

U.S. Representative Joe Kennedy III | Over-the-Counter Hearing Aid Act of 2017 U.S. Representative Joe Kennedy III and President & CEO Gary Shapiro discuss the impactful Over-the-Counter Hearing Aid Act of 2017.

Featured Articles

Article | October 17, 2023
The State of OTC Hearing Aids, One Year Later

On October 17, 2022, the lives of millions of adults with mild to moderate hearing loss in the U.S. changed. That’s the day they were able to buy over-the-counter (OTC) hearing aids for the first time. One year later, brands have come to market with hearing solutions that are accessible, innovative and life-changing for countless Americans.

Article | November 15, 2022
Sleek Earbuds Are OTC Hearing Aids

Find out how Nuheara is reimagining the hearing aid as a stylish tech device that can improve hearing by 30%.

i3 | January 18, 2023
Hearing Health’s Watershed Moment

While it took nearly a decade to disrupt the hearing aid market’s status quo, recent efforts resulted in a new category of OTC hearing aids, which will benefit tens of millions of consumers who experience 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.

The CTA Foundation

Through our extensive and dynamic network, we bring technology to those most in need — seniors and people with disabilities. It's more than just devices. We give people freedom, independence, purpose and most importantly, vital connections.