The FDA’s final rule takes effect in 60 days. Industry representatives say device-makers are largely ready to launch new products, though some may need time to update labeling and packaging or to comply with technical details in the rule.
Dr. Robert Califf, the FDA commissioner, said the move is meant to “unleash the power of American industry” in a way that could have global influence.
“Hearing loss has a profound impact on daily communication, social interaction and the overall health and quality of life for millions of Americans,” Califf said during a Tuesday press briefing. “This is a tremendous worldwide problem where I think American ingenuity can make a huge difference.”
The White House also hailed the move as a signature accomplishment for President Joe Biden, who was expected to sign the Inflation Reduction Act on Tuesday. The change eliminates the requirement to see an audiologist for a hearing examination and fitting, a process rarely covered by insurance.
Federal officials estimated $2,800 in savings on the cost of a pair of hearing aids. Brian Deese, White House director of the National Economic Council, said making the change was a “top priority” for the president.
“This is going to make a really concrete difference in the lives of millions of Americans,” Deese said.
Hearing loss is associated with cognitive decline, depression, isolation and other health problems in older adults. Yet the barriers to getting hearing help have included costs that are not covered by Medicare. There is also stigma — such as appearing “old” — that comes with use. Appreciation for the importance of sharp hearing for adults is also off-kilter: A recent survey found that people ages 50 to 80 were twice as likely to plan on taking their pet to the veterinarian in the coming year than to get their hearing checked.
“It breaks my heart a little bit,” said Sarah Sydlowski, associate chief improvement officer of the Cleveland Clinic Head and Neck Institute and lead author of the study. “I think our biggest challenge as a profession and as a health care system is to make sure that people understand that hearing is incredibly important. It deserves their attention, it deserves their action.”
The move has rankled some of the nation’s audiologists, the professionals who guide people through the process of choosing the best hearing aid, adjusting the settings and achieving the right fit. The new move eliminates the long-standing requirement that consumers start the process of getting a hearing aid with them. But some in the profession see opportunity.
“The hearing health care professional is not going to go away,” said Barbara Kelley, executive director of the Hearing Loss Association of America, which represents audiologists and consumers. “The over-the-counter rule opens a new avenue that is huge for adults with mild to moderate hearing loss to take that step sooner than later. And that’s what we’re really excited about.”
The change has been percolating for years. In 2016, a proposal for the FDA to approve over-the-counter hearing aids for adults with mild to moderate hearing loss came out in a National Academies report. The following year, Sens. Chuck Grassley, R-Iowa, and Elizabeth Warren, D-Mass., introduced a bill enabling the agency to make the change that was signed into law.
The process to finalize regulations has moved slowly since then, with some conflict over details, like how the federal rule would interact with state laws on hearing aid returns or warranty policies and how much the devices should amplify sound.
Biden issued an executive order in July 2021 calling for greater competition in the economy, which included a call for the rule “to promote the wide availability of low-cost hearing aids” to be published.
That rule came out in the fall, followed by a period of public comment. The Hearing Industries Association, an industry group, submitted a 45-page comment letter warning the FDA about companies that had come on the market in 2018, after the initial law passed, selling hearing aids that “were ineffective, of poor quality, and in some cases, dangerous.” The organization offered detailed advice on how to avoid a repeat scenario.
“We applaud the action to increase access to care for persons who have difficulty and encourage them to seek a professional,” to help navigate their options and the fitting process, said Kate Carr, president of the trade group. Other organizations raised concerns that the FDA would be creating a safety issue by allowing new hearing aid makers to make devices that allow users to hear loud sounds.
Warren and Grassley had released a joint report accusing the “dominant hearing aid” makers of engaging in an “astroturf lobbying” effort by flooding the FDA with repetitive comments steering the agency toward a new generation of hearing aids that would be “less effective, protecting manufacturers’ existing market share and locking in their competitive advantage.”
“The logic is simple: The less effective an OTC hearing aid is, the more likely consumers will be forced to abandon these options and instead opt for more expensive, prescription devices sold by the manufacturers that dominate this line of business,” the senators’ investigative report said.
The FDA reviewed more than 1,000 comments submitted about the rule and made a handful of changes in the final version released Tuesday. They include lowering the maximum sound output of the devices and revising the insertion depth limit in the ear canal. The rule also requires that the hearing aids have a user-adjustable volume control and simplified wording on the product label.
This article originally appeared in The New York Times.