On Aug. 16, the FDA ruled that hearing aids may be sold over the counter to adults without a prescription. It’s a move that proponents believe will help many Americans obtain hearing assistance that otherwise would have been prohibited by cost and the need for a doctor’s exam. When will OTC hearing aids be available?
“Hearing loss has a profound impact on daily communication, social interaction, and the overall health and quality of life for millions of Americans,” stated Dr. Robert Califf, commissioner of the FDA. The cost of hearing aids will be significantly reduced for those who don’t see an audiologist for an exam and fitting.
Federal officials estimate that OTC hearing aids could reduce costs by $2,800.
The typical savings for a set of hearing aids, federal officials have estimated, will be around $2,800. That’s simply due to the new FDA ruling enabling individuals to purchase hearing aids without first having to see an audiologist for a hearing exam and a fitting. These parts of the process aren’t always covered by insurance.
In 2016, the National Academies of Science, Engineering and Medicine made a proposal to the FDA to allow OTC hearing aid purchases. Senators Elizabeth Warren and Chuck Grassley introduced a bill allowing the FDA to pursue that plan. Last fall, the FDA proposed a measure allowing brick-and-mortar stores to sell hearing aids over-the-counter to people without a prescription.
White House director of the National Economic Council Brian Deese said the change in requirements was a “top priority” for President Biden that would “make a really concrete difference in the lives of millions of Americans.”
Over-the-counter hearing aids could be available in a couple of months.
Although some audiologists may resist the move as it removes the need for some of their examinations and fittings, Barbara Kelley, executive director of the Hearing Loss Association of America said, “The hearing health care professional is not going to go away.”
As NPR noted, people could be able to purchase hearing aids over-the-counter as soon as mid-October. The new FDA guidelines take effect in 60 days. The rule applies to people aged 18 and older who have “mild to moderate hearing impairment.” The FDA says it could impact approximately 30 million Americans who fit that description.
The final ruling issued by the FDA includes measures about lowering the maximum sound output of devices and a revision to the insertion depth limit in the ear canal. OTC hearing aids will have to have simple product labeling and user-adjustable volume control.
In addition to reducing costs, the rule could promote competition in the industry.
The 2021 “Executive Order on Promoting Competition in the American Economy” made by President Biden urged the FDA to expedite the ruling on OTC hearing aids. The order called for greater competition within the economy, including in the hearing aid industry.
Senators Warren and Grassley also released a report in June that showed five hearing aid manufacturers dominate over 90 percent of the market. They also claimed that those companies engaged in “astroturf lobbying” campaigns. The campaigns were said to flood the FDA with negative comments to distort public perception of the proposal.