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FDA Office of Minority Health and Health Equity

August 16, 2022

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

More Affordable Hearing Aids Could Be in Stores as Soon as Mid-October

Today, the U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans. This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist.

The rule is expected to lower the cost of hearings aids, furthering the Biden-Harris Administration’s goal of expanding access to high-quality health care and lowering health care costs for the American public. It is designed to assure the safety and effectiveness of OTC hearing aids, while fostering innovation and competition in the hearing aid technology marketplace.

Today’s action follows President Biden's Executive Order on Promoting Competition in the American Economy, which called for the FDA to take steps to allow hearing aids to be sold over the counter and set a swift 120-day deadline for action, which the FDA met. In 2017, Congress passed bipartisan legislation requiring the FDA to create a category of OTC hearing aids, but it was not fully implemented until now. Consumers could see OTC hearing aids available in traditional retail and drug stores as soon as mid-October when the rule takes effect.

“Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” said Health and Human Services Secretary Xavier Becerra. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”

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