Hearing aids will soon be easier to obtain for millions of Americans after the FDA issued new guidance to create a new category of over-the-counter products.
The FDA issued a final rule to establish the new category on Tuesday, which will enable 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.
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The ruling is expected to lower the cost of hearing aids. President Joe Biden signed an Executive Order calling for the FDA to allow hearing aids to be sold over the counter.
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.”
Close to 30 million adults in the U.S. could benefit from hearing aid use. Individuals with permanent hearing impairment can use hearing aids to help make speech and sounds louder, improving the ability to communicate effectively with others.
The OTC category established in this final rule applies to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild to moderate hearing impairment. Hearing aids that do not meet the requirements for the OTC category (for example, because they are intended for severe hearing impairment or users younger than age 18) are prescription devices.