FDA Approves New Category of Hearing Aids

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The Food and Drug Administration (FDA) finally issued its ruling establishing the guidelines for over-the-counter (OTC) hearing aids. Released on August 16, 2022. It is part of a broader effort to expand access to affordable hearing care.

The new product category of OTC hearing aids has been established to address the perceived mild to moderate hearing loss in those 18 years old or older. Adults who have trouble hearing will now be able to access these affordable hearing aids without the need for a medical exam, prescription, or professional fitting.

FDA Approves “Over-The-Counter” Hearing Aids

Improved access to affordable hearing care products has been a public health issue. As the lead federal agency supporting research to prevent, detect and treat hearing loss, the NIDCD has made affordable hearing care access a priority.

More than a decade ago, they brought together researchers, hearing care professionals, and representatives from federal agencies to develop a research agenda focused on improving the accessibility and affordability of hearing care. Since then, the NIDCD has supported more than 60 research projects in that area, including a study showing that people with hearing loss can independently and successfully adjust hearing aid settings on their own.

In 2016, the NIDCD co-sponsored a consensus report from the National Academies of Sciences, Engineering, and Medicine (NASEM) recommending that the FDA create and regulate a new category of OTC hearing aids to improve access to hearing aids for adults with perceived mild to moderate hearing loss. 

At nearly the same time, the President’s Council of Advisors on Science and Technology (PCAST) developed an independent report, Aging America & Hearing Loss: Imperative of Improved Hearing Technologies (PDF). The consistent recommendations from non-government and government agencies, combined with the NIDCD’s targeted research portfolio, provided a critical foundation for this monumental regulation.

As a result of these research and policy efforts, hearing aids for many adults will become less expensive and easier to obtain, potentially improving the health and well-being of millions of Americans. The FDA and NIDCD applauds this meaningful step toward improving hearing health care and commends all who contributed to this effort.

For more information on affordable OTC hearing aid options, please visit HearSource.com.