Over-the-Counter Hearing Aids — Using Regulatory Policy to Improve Public Health

NEJM June 3, 2023
Frank R. Lin, M.D., Ph.D., and Shelly Chadha, M.B., B.S., Ph.D.

On October 17, 2022, the Food and Drug Administration (FDA) enacted regulations permitting the sale of a new class of over-the-counter (OTC) hearing aids that would be available to adults without the need to see a health professional.¹ This action represented an attempt to help address the long-standing public health and market failure of hearing loss remaining largely untreated in U.S. adults. This public health challenge is not unique to the United States, however, and the introduction of OTC hearing aids in the United States may influence the hearing-care market in other countries in the coming years.

Studies over the past decade have revealed the public health implications of hearing loss in older adults, and hearing loss is now considered...

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