The federal government is about to make it easier for you to stick tiny gadgets in your ears. No, not another set of AirPods or Galaxy Buds, but actual hearing aids.
The Food and Drug Administration announced Tuesday that it has proposed a rule authorizing over-the-counter sales of hearing aids for people 18 and over experiencing “mild to moderate hearing loss.” The current restrictions on their sale, which can include a medical exam or an audiologist’s fitting, have forced many Americans to go without.
“Approximately 15% of American adults (37.5 million) age 18 and over report some trouble hearing,” the FDA notice says (apparently citing government data published in the mid-2010s). “However, despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid use one.”
A survey conducted in 2018 found that Consumer Reports members typically paid $2,588 out of pocket for hearing aids. More than half of the 15,558 respondents said their insurance paid none of those upfront costs. Medicare doesn’t cover hearing aids at all.
As The Washington Post’s Katie Shepherd outlined in a story on Tuesday, this reform has taken a long and winding road. In October 2015, President Obama’s Council of Advisors on Science and Technology recommended that the FDA “enable a hearing-aid prescription process similar to what is available for eyeglasses and contact lenses.”
In 2017, a bipartisan group of legislators led by Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) introduced a bill mandating that, which President Trump then signed into law as part of the FDA’s annual reauthorization act. The FDA missed the fall 2020 deadline set forth in that law, but President Biden’s July 9 executive order to promote competition instructed the agency to file this regulation by November.
The FDA rule now enters a 90-day period for public comment.
When could we finally see hearing aids on sale in stores and online? In a Tuesday interview with the health-news publication Stat, Sen. Warren suggested retail availability will come only weeks after the comment period closes on Jan. 18: “Finally it’s moving and by early next year hearing aids should be readily available over the counter.”
But the senator also notes how long this policy-making process had ground on, telling Stat’s Nicholas Florko that the Trump administration could have published this rule in 2017: “Consumers would have seen price drops back then, but when industry profits hang in the balance, there is too much delay in the agencies,” she says.
