Yes, over-the-counter hearing aids are now available after a 2017 law paved the way

Update: Americans can start buying hearing aids over the counter beginning Oct. 17, 2022. This story was updated to reflect the eligibility date.

On Aug. 16, the Food and Drug Administration (FDA) finalized approval for people with mild to moderate hearing loss to buy hearing aids over the counter from stores and pharmacies across the country. Americans became eligible to make the purchases on October 17 and do not need a medical exam, prescription  or audiologist fitting adjustment.

A tweet from The White House said making hearing aids available over the counter would “lower the price of a pair by nearly $3,000 – providing more breathing room for an estimated 30 million Americans.”

In August, following the FDA’s approval,  some people on social media said a law signed by former President Donald Trump paved the way for it to happen. Sen. Elizabeth Warren (D-Mass.) also tweeted that legislation she brought forth with Sen. Chuck Grassley (R-Iowa) in 2017 helped make it happen.

THE QUESTION

Did a law signed in 2017 pave the way for over-the-counter hearing aids?

THE SOURCES

• Food and Drug Administration (FDA)
• Food and Drug Administration (FDA) Reauthorization Act
• Over-the-Counter Hearing Aid Act of 2017
• Congressional Research Service
• Alliance for Aging Research
• Sen. Chuck Grassley (R-Iowa) 
• Sen. Elizabeth Warren (D-Mass.)

THE ANSWER

Yes, a law that passed in 2017 paved the way for over-the-counter hearing aids. Then-President Trump signed the Food and Drug Administration Reauthorization Act, which included language to make hearing aids available over the counter. But a number of politicians and government organizations also had a hand in the policy change. 

WHAT WE FOUND

In August 2017, then-President Donald Trump signed the Food and Drug Administration (FDA) Reauthorization Act (FDARA) into law. 

The law did a number of things:

• Authorized the federal government to charge fees to companies in the pharmaceutical, medical device, and other healthcare industries, which provide some funding for the agency to review products.
• Set the standard for the FDA to set and meet performance goals for the review of medical products, with a goal of getting therapies, medical devices, and other products more quickly to market. 

The FDA works with Congress and holds public meetings to determine what should be included in the Reauthorization Act. Every five years, the Reauthorization Act is introduced to Congress, and signed into law by the president.   

One bill that was passed as part of the 2017 Reauthorization Act was the Over-the-Counter (OTC) Hearing Aid Act, a bipartisan bill brought forth by Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.).

The OTC Hearing Aid Act required the FDA to create a new category of over-the-counter hearing aids that would meet high standards but also provide consumers the option of an FDA-regulated device at lower cost. 

Under this new category, a consumer would also be able to purchase the device without a prescription or exam through in-person transactions, mail, or online.

In the FDA’s Aug. 16, 2022, release about the approval, the administration said even though the 2017 law required the FDA to create a category of over-the-counter hearing aids, it was not fully implemented until President Joe Biden issued an executive order on July 9, 2022.

Biden’s executive order was written to “promote competition in the American economy, which will lower prices for families, increase wages for workers, and promote innovation and even faster economic growth.”

Part of that order directed the Secretary of Health and Human Services to make lower-cost hearing aids available over the counter, as called for by section 709 of the FDA Reauthorization Act of 2017, within 120 days from the time the order was signed.

After the FDA announced the final approval of over-the-counter hearing aids, Warren and Grassley released a joint statement that the Over-the-Counter Hearing Act.

"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 Warren and Grassley. “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.”

So, we can VERIFY that a bill was signed into law in 2017 calling for the FDA to make hearing aids available over the counter, but it took a joint effort from Congress, the FDA and two presidential administrations to make it happen.