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FDA’s new category of hearing aids advances hearing health care

August 16, 2022

An older woman and man are sitting together on a sofa looking at a laptop computer screen. The woman is holding a credit card.

The United States marks a significant milestone in advancing hearing health care, as the Food and Drug Administration (FDA) issued its final rule establishing guidelines for over-the-counter (OTC) hearing aids. This landmark rule, released on August 16, 2022, is part of a broader effort to expand access to high-quality, affordable health care for all Americans. OTC hearing aids are intended to address perceived mild to moderate hearing loss in people 18 or older. Now, millions of adults who have trouble hearing will be able to buy less expensive hearing aids without a medical exam, prescription, or fitting by an audiologist.

The new regulation is the culmination of decades of research efforts by the National Institute on Deafness and Other Communication Disorders (NIDCD) and others exploring key issues faced by people with hearing loss. In the U.S. alone, this serious and often overlooked public health issue affects an estimated 30 million people. Hearing loss is associated with dementia, increased risk of falling, reduced mobility, depression, social isolation, and anxiety.

Improving access to hearing health care is an urgent public health issue. As the lead federal agency supporting research to prevent, detect, and treat hearing loss, the NIDCD has made improving hearing health care access a priority. More than a decade ago, we brought together researchers, hearing health care professionals, and representatives from federal agencies to develop a research agenda focused on improving the accessibility and affordability of hearing health care. Since then, the NIDCD has supported more than 60 research projects in this area, including a study showing that people with hearing loss can independently and successfully adjust the settings on their own hearing aids.

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 both 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 NIDCD applauds this momentous step toward improving hearing health care and commends all who contributed to this effort.

Related information:

Advancing access to hearing health care

Research drives changes to make hearing health care more accessible and affordable

FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans

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