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Food and Drug Administration Tuesday drew a plan making hearing aids available without medical examination, prescription or fitting. The proposed rule, which will create a new category of over-the-counter hearing aids, could help improve access and lower the cost of devices for millions of Americans with mild to moderate hearing impairment.
The rule that has not yet been finalized, the culmination of years of thrust Making medical devices available to more Americans.
Dr. “I think this will be truly transformative for many people who have trouble communicating but don’t have the opportunity or skill to purchase a prescription hearing aid or work with an audiologist,” said Vinay Rathi. He’s an otolaryngologist at Eye and Ear, Massachusetts.
More More than 37 million American adults You have a hearing impairment, according to the National Institute on Deafness and Other Communication Disorders. The majority do not use hearing aids. Some deaf people do not want to use the devices, but others are blocked by access barriers.
“We know that when people find out they have a hearing loss, it takes five to seven years to do something about it,” said Barbara Kelley, executive director of the Hearing Loss Association of America. “And there are many 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 devices that can typically cost around $5,000 a pair and require a visit to an audiologist or technician for testing, fitting and possible adjustments. (Health insurance usually does not cover the cost of hearing aids.)
An otolaryngologist and director of the Johns Hopkins University Cochlear Center for Hearing and Public Health, Dr. “There’s a lot of friction,” said Frank Lin.
In 2015, a scientific advisory committee to President Barack Obama approved the FDA’s create a new category Essential, over-the-counter hearing aids to help drive innovation and cut costs.
Two years later, Congress passed the Over the Counter Hearing Aid Act. Under the legislation, the FDA was supposed to issue draft regulations for over-the-counter hearing aids by August 2020, but the agency missed the deadline.
Dr. Lin said the pandemic may have set the agency down, but developing the rule was also a challenge. “It’s a tall order for the FDA to develop an entirely new class of regulatory that no other country in the world has done,” he said.
President Biden in July executive order stipulates that the draft rule be published by early November.
The proposed rule would allow adults with mild to moderate hearing impairment to purchase certain types of hearing aids over the counter in stores or online. Children and people with severe or profound hearing loss will still need to visit an audiologist or licensed provider.
The rule also sets performance, design and safety standards and outlines labeling requirements for devices.
Dr. “It’s not just that the FDA is opening the floodgates,” Rathi said. “They actually do it in a way that I think makes a lot of sense.”
Dr. Lin said the rule would encourage more companies to enter the hearing aid market, which could encourage competition, allow for scale-up production and ultimately drive prices down.
While it’s hard to predict how the market will evolve, Dr. Over-the-counter hearing aids can eventually be found for a few hundred dollars, Lin said. (While this is significantly 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 release its final rule shortly thereafter.
Ms. Kelley said the Hearing Loss Association of America will carefully review the rule and make sure it includes appropriate consumer protection measures. Educating the public about new, over-the-counter devices and making sure people know when to seek professional medical care will also be crucial, he added.
But the group was excited about the possibilities and said: “It opens a whole new way to access care services.”
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