November 16, 2020

Senators Warren and Grassley Urge FDA to Initiate Overdue Rulemaking So That Hearing Aids Can Be Made Available Over-the-Counter

Warren and Grassley's Over-the-Counter Hearing Aid Act was signed into law in 2017 and requires the FDA to issue draft rules by August 2020, but the FDA has yet to do so; Hearing loss continues to be a problem for millions of Americans, but only around 14 percent of Americans with hearing loss use hearing aids

Text of Letter (PDF)

Washington, DC - United States Senator Elizabeth Warren (D-Mass.), a member of the Senate Health, Education, Labor and Pensions Committee, and Senator Chuck Grassley (R-Iowa), Chairman of the Senate Finance Committee, urged the Food and Drug Administration (FDA) to initiate its overdue rules for over-the-counter (OTC) hearing aids without further delay. Senators Warren and Grassley's Over-the-Counter Hearing Aid Act, which was signed into law in 2017 to remove outdated regulations blocking consumer access to affordable hearing aids, required the FDA to issue these proposed regulations no later than August 18, 2020.

According to the National Institute on Aging, nearly one in three Americans between the ages of 65 and 74, and almost half of people over the age of 75, have difficulty hearing. 

"Hearing loss is one of the most common conditions affecting older Americans," the senators wrote. "Unfortunately, although hearing aids are considered prescription products, they are not generally covered by health insurance or original Medicare and can cost thousands of dollars. Only around 14 percent of Americans with hearing loss use hearing aids."

The Over-the-Counter Hearing Aid Act amends the Food, Drug, and Cosmetic Act and allows the FDA to categorize certain hearing aids as over-the-counter. 

"The impact of the novel coronavirus on the agency's priorities and workload cannot be overstated, and we appreciate the FDA's continued efforts to respond to this global crisis that has profoundly affected so many Americans. However, despite the pandemic, hearing loss continues to be a problem for millions of Americans, and we believe that the FDA must also make issuing the OTC hearing aid regulations a priority, consistent with the law," the senators wrote. 

Their latest letter follows a December 2019 letter in which they also urged the FDA to finalize rules for OTC hearing aids. 

Senator Warren has been working to expand peoples' access to hearing technology and care through some of the following measures:

  • In September 2020, Senators Warren and Shelley Moore Capito (R-W.Va.) introduced Ally's Act, bipartisan legislation that would ensure private insurance companies provide coverage for osseointegrated hearing devices, including bone anchored hearing aids and cochlear implants.
  • In July 2019, Senators Warren and Rand Paul (R-Ky.) announced the reintroduction of the Medicare Audiologist Access and Services Act, which was originally introduced in 2018 and would ensure seniors and people with disabilities on Medicare have access to a full range of hearing and balance health care services provided by licensed audiologists. In May 2020, Senator Warren and Rep. Tom Rice (R-S.C.) led a letter, along with Congressman Matt Cartwright (D-Pa.), Senator Paul, Senator Kyrsten Sinema (D-Ariz.), Congressman Darren Soto (D-Fla.), Congressman Gus Bilirakis (R-Fla.), and Congressman Rodney Davis (R-Ill.), to House and Senate leadership urging them to include provisions of the Medicare Audiologist Access and Services Act in upcoming COVID-19 packages.
  • In December 2016, Senators Warren and Chuck Grassley (R-Iowa), introduced the Over-the-Counter Hearing Aid Act, which they later reintroduced with Senators Maggie Hassan (D-N.H.) and Johnny Isakson (R-Ga.) in March 2017. The bipartisan bill passed in August 2017 and requires the Food and Drug Administration (FDA) to permit the sale of traditional hearing aids over the counter. 
  • She has also partnered with Senator Grassley to encourage the FDA to improve consumer access to hearing aids, and she and Senator Paul have called on Centers for Medicare and Medicaid Services Administrator Seema Verma to remove roadblocks that prevent Medicare beneficiaries with hearing loss from accessing audiology services.

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