FDA finalizes rule enabling access for over-the-counter hearing aids

(ABC 6 News) – The U.S. Food and Drug Administration (FDA) on Tuesday 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 designed to assure the safety and effectiveness of OTC hearing aids, while fostering innovation and competition in the hearing aid technology marketplace.

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.

The new guidelines officially go into effect 60 days following the FDA’s official notice, so consumers could see OTC hearing aids available in traditional retail and drug stores as soon as mid-October.

“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.”

Furthermore, Tuesday’s action correspondingly amends existing rules that apply to prescription hearing aids for consistency with the new OTC category, it repeals the conditions for sale for hearing aids, and it includes provisions that address some of the effects of the FDA OTC hearing aid regulations on state regulation of hearing aids.

Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) issued the following joint statement:

"Five years after our bipartisan Over-the-Counter Hearing Aid Act became law, consumers with mild to moderate hearing loss will finally have access to affordable over-the-counter hearing aids,” said Grassley and Warren. “We’ve pressed the FDA to take action every step of the way – holding both Republican and Democratic administrations accountable – and fought back against entrenched special interests. We are thrilled that the FDA has finalized these guidelines and that safe, effective, accessible and affordable hearing aids will now be available over-the-counter for millions of Americans.”

To read more on the FDA ruling CLICK HERE.