Oct. 19, 2021 -- The FDA issued a long-awaited proposal Tuesday that would offer a new category of affordable over-the-counter hearing aids for nearly 30 million Americans who report mild or moderate hearing loss.
With the proposed rule, you could skip both of those steps and buy hearing aids in retail stores or online. This would make the process easier and more cost-friendly, as well increase access to specialists for many Americans who don’t have it.
“This allows us to put hearing devices more in reach of communities that have often been left out. Communities of color and the underserved typically and traditionally lacked access to hearing aids,” Xavier Becerra, secretary of the U.S. Department of Health and Human Services, said at a news briefing.
The FDA says it’s unclear exactly when the new products will be in stores, but finalizing the ruling is a top priority.
For new products, the ruling is expected to go into effect 60 days after it is finalized. Current products would have 180 days to make changes, according to the FDA.
The American Academy of Audiology said in a statement that it is reviewing the proposed rules and will provide comments to the FDA. But in July, Angela Shoup, PhD, a professor at the School of Behavioral and Brain Sciences at the University of Texas at Dallas, wrote to Becerra with concerns about over-the-counter sales of hearing aids.
“While we certainly support efforts to lower costs and improve access to hearing aids, we have grave concerns about the oversimplification of hearing loss and treatment in the advancement of OTC devices,” she wrote.
“It is through involvement of an audiologist that consumers will achieve the best possible outcomes with OTC hearing aids and avoid the risks of under- or untreated hearing loss,” Shoup said.
The FDA is also proposing labeling requirements for the hearing devices, including warnings, age restrictions, and information on severe hearing loss and other medical conditions that would prompt you to seek treatment from a doctor.
The FDA said that it would closely monitor the marketplace to make sure companies advertising hearing loss products follow federal regulations.
Around 38 million Americans 18 years old and older report having hearing trouble, says Janet Woodcock, MD, acting commissioner of the FDA.
But she says only about 20% of people who could benefit from hearing aids are using them, with barriers to access being a major factor.
The FDA has also updated its guidance on hearing devices and personal sound amplification products.
Personal sound amplification products (PSAPs) are nonmedical devices designed to amplify sounds for people with normal hearing and are usually used for activities like bird-watching and hunting.
Amplification devices are not regulated by the FDA.