The president called on the FDA to make the hearing aids available last year in his executive order Promoting Competition in the American Economy to lower costs and increase competition in certain industries.
The new regulations will create a new category of hearing aids that replace state-level regulations that require patients to visit doctors or audiologists to obtain prescriptions and equipment. The devices will be available to individuals 18 and older with mild to moderate hearing loss in pharmacies, stores and online.
Sen. Elizabeth Warren (D-Mass.), a co-sponsor of the Over-the-Counter Hearing Aid Act, praised the decision on Twitter and credited Biden for moving the issue forward after it stalled at the FDA.
“It took years of hard work, but I’m pleased that millions of Americans — many of whom don’t use hearing aids because they’re too expensive — will soon be able to purchase safe and affordable hearing aids over the counter,” she. posted on Twitter. “This is what it looks like when government works for working people.”
The change is expected to significantly benefit the elderly—individuals who are more likely to experience hearing loss and have fixed incomes—as well as those in poor and rural communities who have fewer audiologists.
The move comes more than four years after Congress ordered the FDA to create regulations for over-the-counter devices.
“This rule is expected to help us achieve quality and affordable access to health care for millions of Americans in need,” said Health and Human Services Secretary Xavier Becerra. “Today’s action by the FDA represents an important milestone in making hearing aids more cost-effective and accessible.”
Average current price of hearing aids more than $5,000 per pair, and they are usually not covered by traditional Medicare or other insurers. Vice President Harris said the rule would reduce the cost of hearing aids by hundreds and even thousands of dollars.
“Every American has the right to affordable health care,” she said in a statement Tuesday. “Today our administration has taken another step forward in our fight to protect this right.”
A study published in Social Science and Medicine in 2019 found that counties with the highest numbers of seniors with hearing loss often had fewer audiologists available, in part because doctors tend to practice in younger, more affluent urban areas.
Stigma, lack of access and confusion about how to get the best health care often prevent people — especially older Americans — from taking care of their hearing health, said Barbara Kelley, executive director of the Hearing Loss Association of America. This option will benefit countless Americans who may need hearing assistance at perhaps restaurants or large family gatherings without necessarily seeking a hearing professional, she said.
“For years, we’ve worked for affordable and accessible hearing health care, and this is a big step in getting people to pay attention to their hearing health sooner rather than later,” Kelley said. “And it just provides another path—a new path really—for adults with mild to moderate hearing loss who can take a step on their own.”
Although about 38 million adults in the United States report hearing loss, few have tried the devices. Among adults over 70 with hearing loss, only one in three wears one, according to data collected in the National Health Interview Survey.
The FDA’s move follows years of federal efforts to remove barriers between patients and over-the-counter hearing aids. In 2015, the President’s Council of Advisors on Science and Technology under Barack Obama recommended that the FDA create a new category of “basic” hearing aids that could be purchased without a prescription or a doctor’s visit. Two years later, President Donald Trump signed the Over-the-Counter Hearing Aid Act of 2017, which gave the FDA three years to adopt the new rules.
The FDA missed that 2020 deadline, but President Biden renewed the push in July 2021 when he signed an executive order that set a November deadline for a new rule proposed by the federal agency.