The proposed rule could make it easier for Americans with mild to moderate hearing impairments to get the devices.
The Food and Drug Administration on Tuesday outlined a plan to make hearing aids available without a medical exam, prescription or fitting. The proposed rule, which would create a new category of over-the-counter hearing aids, could help improve access to and reduce the cost of the devices for millions of Americans with mild to moderate hearing impairments.
The rule, which has not yet been finalized, is the culmination of a yearslong push to make the medical devices available to more Americans.
“This is going to be, I think, really transformative for a lot of people who are struggling to communicate but may not have the means or the ability to buy a prescription hearing aid or work with an audiologist,” said Dr. Vinay Rathi, an otolaryngologist at Massachusetts Eye and Ear.
More than 37 million American adults have a hearing impairment, according to the National Institute on Deafness and Other Communication Disorders. The majority do not use hearing aids. Some people with hearing impairments do not want to use the devices, but others are stymied by numerous barriers to access.
“We know that when people find out they have a hearing loss they take five to seven years before they do something about it,” said Barbara Kelley, the executive director of the Hearing Loss Association of America. “And there’s a lot of reasons for that: One is cost, one is stigma, one is access to care.”
Under current regulations, which are more than 40 years old, only providers licensed by the states can prescribe and sell the devices, which can often cost roughly $5,000 a pair, and require visiting an audiologist or technician for testing, fitting and potential adjustments. (Health insurance typically does not cover the cost of hearing aids.)
“There’s a lot of friction,” said Dr. Frank Lin, an otolaryngologist and director of the Cochlear Center for Hearing and Public Health at Johns Hopkins University.
In 2015, a scientific advisory committee to President Barack Obama issued a report recommending that the F.D.A. create a new category of basic, over-the-counter hearing aids to help encourage innovation and drive down costs.
Two years later, Congress passed the Over-the-Counter Hearing Aid Act. Under the legislation, the F.D.A. was supposed to issue draft regulations for nonprescription hearing aids by August 2020, but the agency missed the deadline.
The pandemic may have set the agency back, Dr. Lin said, but developing the rule was also a challenging task. “It’s a tall order for the F.D.A. to completely develop a completely new regulatory class that no other country in the world is doing,” he said.
In July, President Biden issued an executive order requiring that the draft rule be issued by early November.
The proposed rule would allow adults who have mild to moderate hearing impairments to purchase certain kinds of hearing aids in stores or online without a prescription. Children and people with severe or profound hearing loss would still be required to visit an audiologist or licensed provider.
The rule also establishes performance, design and safety standards, and outlines labeling requirements for the devices.
“It’s not just that the F.D.A. is opening up the floodgates,” Dr. Rathi said. “They’re actually doing it in what I think is a very well-reasoned way.”
The rule is likely to encourage more companies to enter the hearing aid market, which could encourage competition, allow manufacturing at scale and ultimately drive prices down, Dr. Lin said.
Although it is hard to predict how the market will develop, Dr. Lin said that over-the-counter hearing aids might eventually be available for a few hundred dollars. (Although that is substantially lower than the current average, that price may still be out of reach for many Americans.)
Members of the public can comment on the new rule for 90 days. The agency will issue its final rule soon after that.
The Hearing Loss Association of America will review the rule carefully, Ms. Kelley said, to ensure that it contains appropriate consumer safeguards. Educating the public about any new, over-the-counter devices — and ensuring that people know when they should seek professional medical care — will also be critical, she added.
But the group was excited about the possibilities, she said: “It opens up a whole new avenue of access to care.”
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