The president called on the FDA to make hearing aids available over the counter last year in his Promoting Competition in the American Economy executive order to help lower costs and increase competition in certain industries.
The devices will be available for individuals 18 and older with mild to moderate hearing loss. They could be purchased at pharmacies, stores and online.
The move comes more than four years after Congress ordered the FDA to craft regulations for over-the-counter devices. The new regulations will create a new category of hearing aids that will supersede state-level regulations requiring patients to visit physicians or audiologists to get prescriptions and fittings.
Health and Human Services Secretary Xavier Becerra said Tuesday that this decision is the fulfillment of a long-term goal.
“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,” he said. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”
The current price of hearing aids averages more than $5,000 per pair and they are not typically covered by traditional Medicare or other insurers. Supporters of the new proposal have long argued that over-the-counter models would be a fraction of that cost.
This change is expected to significantly benefit older adults — individuals who are most likely to experience hearing loss and to be on a fixed income — as well as those in poor and rural communities that have fewer audiologists.
A study published in Social Science and Medicine in 2019 found that the counties with the largest numbers of older adults with hearing loss often had fewer available audiologists, in part because the doctors tend to practice in younger, wealthier urban areas.
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 have ever worn one, according to data collected in the National Health Interview Survey.
The FDA’s move follows years of federal efforts to remove obstacles 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 enact the new rules.
The FDA missed that 2020 deadline, but President Biden renewed pressure in July 2021 when he signed an executive order that set a November deadline for a new proposed rule from the federal agency.
George is Digismak’s reported cum editor with 13 years of experience in Journalism