The action comes nearly 5 years after Congress passed ato allow over-the-counter sales for people with mild to moderate .
Those withor people under 18 years old would still need to see a doctor or specialist for a hearing .
In the United States, access tocan be difficult and . Usually, patients have to go see their health care providers for a prescription. Then, they go to an , or a hearing aid specialist, to get the devices fitted.
With the proposed rule, patients could skip both of those steps and buy hearing aids in retail stores or. 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 hearingmore in reach of communities that have often been left out. Communities of color and the underserved typically and traditionally lacked access to 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 Mr. 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 anthat consumers will achieve the best possible outcomes with OTC hearing aids and avoid the risks of under- or untreated hearing loss,” Dr. Shoup said.
This new category would apply to certain airhearing aids, which are worn inside of the ear and improve hearing by boosting sound into the ear .
The FDA is proposing labeling requirements for the hearing devices, including warnings,restrictions, and information on hearing loss and other medical conditions that would prompt patients to seek treatment from their doctors.
The FDA said that it would closely monitor the marketplace to make sure companies advertising hearing loss products follow federal regulations.
There are a number of reasons for hearing loss, includingto extremely loud noises, and medical conditions. Approximately 38 million Americans 18 years old and older report having trouble, said Janet Woodcock, MD, acting commissioner of the FDA.
About 20% of people who could benefit from hearing aids are using them, withto access being a major factor, she added.
“Hearing loss can have a profoundon daily communication, social interaction, and overall health and of life for millions of Americans,” Dr. Woodcock said.
The FDA has updated itson hearing devices and personal sound amplification products.
Personal sound amplification products () are nonmedical devices designed to amplify sounds for people with normal hearing and are usually used for activities such as bird-watching and hunting.
Amplificationare not regulated by the FDA.
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