FDA Gives Millions of Americans Access to Over-the-Counter Hearing Aids

WASHINGTON — The Food and Drug Administration issued a final rule Tuesday morning that promises to provide millions of Americans with access to lower cost, over-the-counter hearing aids.

The action, which follows an executive order signed by President Joe Biden to promote competition in the U.S. economy, establishes a new category of over-the-counter hearing aids for those with perceived mild to moderate hearing impairments.

As a result of today’s action, consumers could see over-the-counter hearing aids available in traditional retail and drug stores as soon as mid-October when the rule takes effect.

What it all means is that consumers will soon be able 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.

According to administration officials, the new rule is expected to lower the cost of hearing aids generally, while still ensuring their safety and effectiveness.

At the same time, it will also foster innovation and competition in the hearing aid technology marketplace, they said.

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. 

“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,” he said

It is estimated that 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. 

But many hearing aids can be expensive. The final rule aims to stimulate competition and facilitate the sale of safe and effective OTC hearing aids in traditional retail stores or online nationwide, providing consumers with perceived mild to moderate hearing loss with improved access to devices that meet their needs and are less expensive than current options. 

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Dr. Robert Califf. 

“Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online,” he said.

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) will continue to be available only by prescription.

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