Instead of getting a prescription, visiting a hearing health professional, and getting customized formulations, people with mild to moderate hearing loss will be able to purchase hearing aids directly in the store or online.
Food and Drug Administration Commissioner Dr. Robert Califf said the move would make hearing aids more widely available across the country.
About 1 in 8 people in the United States age 12 or older have hearing loss in both ears, and the rate increases significantly with age. About a quarter of people between the ages of 65 and 74 have a hearing loss, and this percentage rises to 50% by about age 75.
The new devices won’t be free, but the FDA estimates that the new rule could mean savings of about $2,800 per pair. Califf said people could see over-the-counter hearing devices on the market as early as October.
“Today’s action will not only help adults who have observed mild to moderate hearing loss gain access to more affordable innovative production options, but we expect it will unleash the power of American industry to improve technology in a way that will impact an enormous burden of disability from hearing loss affecting the world.” “.
Long Base Journey
Congress passed legislation to create a class of OTC hearing aids with broad bipartisan support, and President Trump signed it into law in 2017.
The Food and Drug Administration initially said the pandemic had delayed implementation of the rule. On Tuesday, the agency said it also had a lot of public comment to go through.
On Tuesday, the American Hearing, Speech-Language Association praised the Food and Drug Administration’s work.
“ASHA fully supports the creation of this new class of over-the-counter hearing devices, which will increase the availability and affordability of hearing aids for many Americans,” said Janice R. Trent, vice president of hearing practice on the group’s board of directors. directors. “It is important for the public to understand that these devices are only intended for adults with mild to moderate hearing loss, and to strongly consider getting a hearing evaluation by a certified audiologist as a first step before purchasing anything.”
Expensive medical device
With this change, many companies are expected to enter the market.
“Reducing health care costs in America has been a priority from day one, and this rule is expected to help us achieve access to affordable, quality health care for millions of Americans in need,” Secretary of Health and Human Services, Xavier Becerra, said in a statement. Tuesday.
How will the new rule work?
Currently, people can only obtain hearing aids with an expensive medical examination or a prescription from a specialist that matches the device for the individual. Audiologists can also adjust it over the course of their life if a person’s hearing worsens.
With an over-the-counter device, buyers may be able to adjust it themselves.
To be allowed on the market, the new rule says, over-the-counter hearing devices will need to meet the US Food and Drug Administration’s high standards for safety, labeling and manufacturing protection like all other medical devices.
“I think today is a special day,” Becerra said. “Americans who need help with their hearing aids—my mom included—help is on the way. So over-the-counter hearing aids—get ready, folks, you save a lot of money, and we all benefit.”
Why are hearing aids important
Hearing aids aren’t just cute so people can hear; It is also essential for physical and mental health.
With hearing aids potentially becoming easier to access, “I have a big smile on my face now,” said Dr. Frank Lane, director of the Cochlear Center for Hearing and Public Health. He has been consulting with the government on this issue for eight years.
Lin said there has been little innovation in this area because of the way the market is organized.
“In 1977, because of technology at the time, the only way for hearing aids to be safe and effective was if they were professionally programmed, installed, and modified by a licensed provider,” Lynn said. “45 years later, those rules are still on the books, but the market and that technology has changed dramatically.
“This will allow companies like Samsung, Apple, Google and companies that make innovative earbuds, they can now enter the market. They couldn’t before.”
He believes that if companies could sell the earbuds for $200, they could easily sell the hearing aids for a similar price.
He said the new rule is a good thing for patients because it shows the government can take action to improve health.
“This was a true bipartisanship,” Lin said. “This is how government should operate.” “This really, really restores my faith in him Government.”
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