(CNN)Long-awaited rule change could make hearing aids cheaper and betterThe U.S. Food and Drug Administration announced on Tuesday.
People with mild to moderate hearing loss can buy hearing aids in-store or online instead of getting a prescription, visiting a hearing specialist, or getting a custom-fit. will be available for purchase.
The move will make hearing aids more widely available across the country, said his FDA Commissioner Dr. Robert Calif.
new devices won't be free No, but the FDA estimates that the new rule will save about $2,800 per pair. And in October, over-the-counter hearing aids could hit the market, Califf said.
"Today's measures not only ensure that adults with mild to moderate hearing loss have access to more affordable and innovative production options, but also empower America's industry. We hope to unlock and improve technology that will impact the enormous burden of hearing loss disability affecting the world," he said on Tuesday. The long road of
On Tuesday, the American Speech-Language Hearing Association applauded the FDA's action.
"ASHA fully supports the creation of this new category of commercial hearing aids that will increase the availability and affordability of hearing aids for many Americans," said Audiology Director. Vice President Janice R. Trent said. Group board practice. “It is important for the public to understand that these devices are only intended for adults with a perceived mild to moderate hearing loss, and as a first step before purchasing anything, it is important that they are certified. strongly consider having your hearing evaluated by an audiologist.”
Expensive medical equipment
The change is expected to bring more companies into the market.
"Reducing healthcare costs in America has been a priority of mine since day one, and this rule will help millions of Americans in need get quality, affordable healthcare." It is hoped that it will help achieve access to health and social services," Health and Human Services Secretary Xavier Becerra said in a statement Tuesday.
How the new regulations work
Currently, obtaining hearing aids requires either a costly medical examination or a hearing aid specialist who specializes in personalized hearing aids. I have to get a prescription from home. If someone's hearing deteriorates, an audiologist can also adjust it for life.
Under new regulations, over-the-counter hearing aids, like all other medical devices, must meet the FDA's high standards for safety, labeling, and manufacturing protection.
"I think today is a wonderful day," said Becerra. "Americans in need of hearing aid help are asking for help, including my mom. Over-the-counter hearing aids are ready. Guys, you can save a lot of money, and we Everyone will benefit.”
Why Hearing Aids Matter
Hearing aids are more than just a convenience to have. They are also essential for physical and mental health.
With hearing aids likely to be easier to access, "I have a big smile on my face now," says Frank Lin, director of the Cochlear Center for Hearing and Public Health. says Dr. He has been consulting with the government on the issue for eight years.
Lin said there has been little innovation in this area because the market is regulated.
"In 1977, with the technology of the time, the only way hearing aids were safe and effective was to be programmed, fitted and professionally adjusted by a licensed provider." It was," Lynn said. “After 45 years, these rules are still in the books, but the market and its technology have changed dramatically. I can. I really couldn't before.
He believes that if companies can sell earbuds for $200, they can easily sell hearing aids for similar prices.
because the new rules show governments can take action to improve health.
"This was truly bipartisan. ' said Lynn. "This has really restored confidence in the government."