FDA decides to make hearing aids available without a prescription


The Food and Drug Administration on Tuesday decided to make hearing aids cheaper and more easily available for consumers to buy over-the-counter or online without a prescription or medical exam — a long-awaited goal for nearly 30 million consumers.

“Starting in mid-October, Americans will be able to purchase more affordable hearing aids over the counter at pharmacies and stores across the country,” President Biden said in a statement Tuesday. “This action delivers on my commitment to lowering costs for American families, saving American families nearly $3,000 for a pair of hearing aids and giving people more choices to improve their health and well-being. -be.”

The president called on the FDA to make hearing aids available without a prescription last year in its executive order on promoting competition in the US economy to reduce costs and increase competition in certain industries.

New regulations will create a new class of hearing aids that will replace state-level regulations requiring patients to seek medical attention or audiologists for prescriptions and adjustments. The devices will be available for people 18 and older with mild to moderate hearing loss in pharmacies, stores and online.

Sen. Elizabeth Warren (D-Mass.), co-sponsor of the over-the-counter hearing aids legislation, praised the decision on Twitter and credited Biden with pushing the issue forward after he was blocked at the FDA.

“It’s taken years of hard work, but I’m glad millions of Americans – many of whom don’t use hearing aids because they’re too expensive – will soon be able to buy safe, affordable hearing aids on sale. free,” she said. tweeted. “This is what it looks like when government works for workers.”

The change is expected to significantly benefit older people – those most likely to suffer from hearing loss and have a fixed income – as well as those in poor, rural communities that have fewer audiologists.

The move comes more than four years after Congress ordered the FDA to develop regulations for over-the-counter devices.

Hearing aids without a prescription or exam? The FDA is taking a big step to make this happen.

“This rule should help us achieve access to quality, affordable health care for millions of Americans in need,” Health and Human Services Secretary Xavier Becerra said. “Today’s action by the FDA represents an important step in making hearing aids more cost-effective and more accessible.”

The current price of hearing aids is on average over $5,000 a pair, and they are usually not covered by traditional health insurance or other insurers. Vice President Harris said the rule would reduce the cost of hearing aids by hundreds, if not thousands, of dollars.

“Every American has the right to affordable health care,” she said in a statement Tuesday. “Today, our administration has taken another step in our fight to protect that right.”

A study published in Social Science and Medicine in 2019 found that counties with the highest numbers of hearing-impaired seniors often had fewer available audiologists, in part because physicians tend to practice in younger, more urban areas. rich.

Stigma, lack of access and confusion about how to get the best health care often prevent people — especially older Americans — from taking care of their hearing health, said Barbara Kelley, executive director of the Hearing Loss Association of America. This option will benefit countless Americans who might need a hearing aid in restaurants or large family gatherings without necessarily seeking out a hearing professional, she said.

“For years, we’ve worked for affordable and accessible hearing health care, and this is a big step forward in getting people to pay attention to their hearing health as early as possible,” Kelley said. “And it just provides another avenue – a new avenue really – for adults with mild to moderate hearing loss who can take a step on their own.”

Although approximately 38 million adults in the United States report hearing loss, few have tried the devices. Of adults over 70 with hearing loss, only one in three have ever worn one, according to data collected as part of the National Health Survey by interview.

The FDA’s decision follows years of federal efforts to break down barriers between patients and over-the-counter hearing aids. In 2015, the President’s Advisory Board on Science and Technology under Barack Obama recommended that the FDA create a new category of “basic” hearing aids that can be purchased without a prescription or doctor’s visit. Two years later, President Donald Trump signed the Over-the-Counter Hearing Aids Act of 2017, which gave the FDA three years to enact the new rules.

The FDA missed that 2020 deadline, but President Biden renewed the push in July 2021 when he signed an executive order setting a November deadline for a new rule proposed by the federal agency.

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