Hearing aids: FDA finalizes rule that should enable cheaper hearing aids

Hearing aids: FDA finalizes rule that should enable cheaper hearing aids
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Hearing aids should be cheaper and possibly better for a long-awaited reason rule change The US Food and Drug Administration announced this on Tuesday.

Instead of getting a prescription, visiting a hearing care professional, and using a custom fit, people with mild to moderate hearing loss will be able to purchase hearing aids directly from a store or online.

This move will make hearing aids more widely available across the country, FDA Commissioner Dr. Robert Califf said.

If hearing loss were officially considered a disability by the government, this would be it the largest disability class in the country.

About 1 in 8 people age 12 and older in the United States have hearing loss in both ears, and this rate increases significantly with age. About a quarter of people aged 65-74 have hearing loss, rising to 50% around age 75.

But just about 16% of the tens of millions of people with hearing loss Hearing aid.

The new devices won’t be free, but the FDA estimates the new rule will mean a savings of about $2,800 per pair. Califf said people could see hearing aids often on the market in October.

“Today’s event will not only help adults with mild to moderate hearing loss gain access to more affordable and innovative manufacturing options, but we also expect to demonstrate the power of American industry to improve technology. The enormous burden of disability from hearing loss affects the world,” he said.

Congress passed legislation to create the OTC hearing aid category with broad bipartisan support and President Trump He signed the law in 2017.

But no action was taken and Sen. Elizabeth Warren, the bill’s sponsor, gave the FDA until August 2020 to issue regulations. He and the sponsor Sen. Chuck Grassley is serious letters Urges FDA to take action.

President Biden in July 2021 signed an executive order created in part to speed things up.

The FDA initially said the pandemic delayed implementation of the rule. The agency said Tuesday that it also has plenty of public comments to go through.

During the period of public health commentary, some health associations are listening presented their concerns About the proposed changes, he suggests that the devices will still need the help of a specialist.

The American Speech-Language-Hearing Association on Tuesday praised the FDA’s action.

“ASHA fully supports the creation of this new category of over-the-counter hearing aids that will increase the availability and affordability of hearing aids for many Americans,” said Janice R. Trent, vice president of audiology practice for the group’s Board of Directors. directors “It is important that the public understand that these devices are only for adults with mild to moderate hearing loss and should seriously consider getting a hearing evaluation by a certified audiologist as the first step before purchasing anything.”

The rule does not change how hearing aids are covered. While private insurers will pay for treatment after the loss of a limb or even cover the cost of Viagra, most do not cover hearing aids. Main Medicare doesn’t pay for them either, and only half of state Medicaid programs do.

Hearing aids are not cheap. According to a study published in 2020, people spend at least $4,000 out of pocket for devices for both ears. JAMA. Prices may vary: Major retailers may offer for about $1,400 a pair, but some can cost as much $6,000 an eardepending on the technology.

Five major companies now control 90% global market for hearing aids. This kind of consolidation has meant that there is little price competition, and high prices can be a big reason why most people who need hearing aids don’t have them.

More companies are expected to enter the market with the change.

Experts believe will also develop cheaper over-the-counter devices in addition to current offerings from existing manufacturers.

“Reducing health care costs in America has been a priority for me since day one, and this rule is expected to help us get quality, affordable health care to millions of Americans who need it,” Health and Human Services Secretary Xavier Becerra said in a statement. Tuesday.

Currently, people can only get hearing aids with an expensive medical examination or a prescription from a specialist who will fit the device to the individual. If someone’s hearing becomes impaired, audiologists can adjust it for life.

With an over-the-counter device, buyers can adjust them themselves.

The new rule The FDA only applies to certain types of hearing aids. People with severe hearing loss and those under 18 will still need a prescription.

To be allowed on the market, the new rule says that over-the-counter hearing aids must meet the FDA’s high standards for safety, labeling and manufacturing safeguards, just like all other medical devices.

“I think today is a great day,” Becerra said. β€œIt will help Americans who need help with hearing aids, including my mother. So over-the-counter hearing aids β€” get ready, folks, you’re going to save a lot of money, and we’re all going to benefit.”

Hearing aids are not just pleasant for people to hear; they are also important for physical and mental health.

People with hearing loss who do not have hearing aids report more bad health In general, and they are less likely to leave the house or exercise, research has revealed.

There is a link hearing loss and between general weakness and increasing risk of fallingis the second leading cause of accidental deaths in the world World Health Association.

A number of studies have also found a link between hearing loss worse mental health and psychosocial health.

May cause hearing loss depressionloneliness and isolateeven dementia.

“I have a big smile on my face right now,” said Dr. Frank Lin, director of the Cochlear Center for Hearing and Public Health. I have been consulting with the government on this issue for eight years.

Because of the way the market is regulated, there is very little innovation in this space, Lin said.

“In 1977, with the technology at the time, the only way for hearing aids to be safe and effective was for them to be programmed, fitted and professionally adjusted by a licensed provider,” he said. “Fast forward 45 years later, those regulations are still on the books, but the market and technology have changed dramatically.

“This will allow companies like Samsung, Apple, Google, companies that already produce innovative headphones to enter the market now. They really couldn’t do it before.”

He believes that if companies can sell headphones for $200, they can easily sell hearing aids for the same price.

He said the new rule is a good thing for patients because it means the government can take action that improves health.

“It was a real bipartisanship. This is how government should work,” Lin said. “It really restores my confidence government.”

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