Consumers with mild to moderate hearing loss will soon be able to purchase over-the-counter hearing aids without having to see an audiologist. The Food and Drug Administration on Tuesday released final rules governing the design and sale of over-the-counter hearing aids, five years after the law legalizing the devices was passed.
“I have a big smile on my face,” said Frank Lin, PhD, director of the Johns Hopkins Cochlear Center for Hearing and Public Health, who testified before Congress in support of the law when it was being debated in 2017. “It’s a win-win solution for consumers.”
About 15% of all American adults have some level of hearing loss, according to the FDA, but currently only about one-fifth of people who could benefit from a hearing aid use one. Hearing aids can cost thousands of dollars and are not covered by Medicare. The Over-the-Counter Hearing Aids Act of 2017 aimed to address this issue by reducing costs and other barriers to accessing hearing aids.
“This rule should help us achieve access to quality, affordable health care for millions of Americans in need,” Xavier Becerra, secretary of the Department of Health and Human Services, said in a statement. hurry. “Today’s action by the FDA represents an important step in making hearing aids more cost-effective and more accessible.”
According to a statement from President Biden today, over-the-counter hearing aids could be available in stores as early as mid-October.
What the FDA rules say about hearing aids
Rules published by the FDA define the category of over-the-counter hearing aids and outline how they will be sold and regulated. This includes technical specifications that manufacturers must meet to ensure that over-the-counter hearing aids are safe, effective, and accessible to consumers with mild to moderate hearing loss.
The final rules retain many features from the draft version, which was published in October 2021. They impose an overall limit for the volume of an over-the-counter hearing aid: 111 decibels in general and 117 decibels while certain sounds controls are activated. These limits are slightly lower than what the agency originally proposed.
Other changes from the draft include a requirement that all over-the-counter hearing aids allow users to adjust the volume, and specifications to make product labeling and instructions understandable to consumers. Barbara Kelley, executive director of the Hearing Loss Association of America (HLAA), said she was pleased to see the FDA require labeling to clearly indicate whether a smartphone or other additional device is needed to use a hearing aid while listening. over-the-counter, as is likely with some upcoming products.
The final rules are however very close to the draft. This is despite intense opposition from the traditional hearing aid industry, which is dominated by five major companies, according to a June 2022 report compiled by Senators Elizabeth Warren (D-Massachusetts) and Chuck Grassley (R-Iowa). Grassley and Warren together proposed the Over-the-Counter Hearing Aids Act of 2017. Opponents of the new rules have argued that over-the-counter hearing aids should be more strictly limited in how loud they output and how much they could amplify incoming sound – the idea being that excessive amplification could actually damage hearing.
But supporters of the rules have pointed out that such limitations would mean fewer consumers could benefit from the devices. Lin applauded the FDA for largely maintaining what the agency originally proposed, with only a minor change to the total production limit.
“It doesn’t unnecessarily cripple these devices from the start,” he said. “In short, the FDA got it right.”
Companies will also be motivated to design hearing aids that people will actually want to use.
“A company is unlikely to add ridiculous over-amplification of sound, because the consumer probably wouldn’t like it,” said Nicholas Reed, AuD, assistant professor of epidemiology and audiology at Johns Hopkins Cochlear Center.
The final rules maintain a measure that ensures that federal rules on over-the-counter hearing aids will prevail (in other words, essentially override) all state-level rules that impose additional hurdles on consumers seeking to purchase hearing aids. over-the-counter hearing aids. Advocates, including experts from the President’s Advisory Council on Science and Technology and the National Academies of Sciences, Engineering and Medicine, have argued that the complex web of state laws restricting access to devices hearing aids is not good for consumers. The new rules render many of these laws moot. In a call with the media this week, Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said states will still be able to enforce consumer protections, such as requiring warranties or reasonable return policies for over-the-counter products. hearing aids.
The new hearing aid market
Over-the-counter hearing aids are not intended for use by persons under the age of 18. The FDA said children and teens still need the advice of a hearing health professional to get them.
And not all hearing aids will be available over the counter under the new rules. Some hearing aids, especially those for people with more severe hearing loss, will remain prescription devices. Consumers will need to see an audiologist or other hearing care provider to obtain them.
The rules essentially create two categories, so all hearing aids will now be either prescription devices or over-the-counter devices. This should de facto eliminate a category of hearing aids that currently exists, often referred to as direct-to-consumer hearing aids, which have long been available without the intervention of a doctor when purchased online or by mail order.
Manufacturers could start selling over-the-counter hearing aids within two months of the rules officially taking effect, assuming they have products ready to comply with the new regulations. Lin said he thinks some companies are ready to go and will be able to sell over-the-counter products this fall. Proponents of the new rules expect consumers will soon have more affordable choices and possibly more options and features to choose from.
Kelley of the Hearing Loss Association of America said many consumers may not be sure if an over-the-counter hearing aid is a good option for them, or if they should see an audiologist or other health care provider. health for a hearing problem. The HLAA website offers advice on how to determine if an over-the-counter medication might be right for you. And Northwestern University’s Consumer Ear Disease Risk Assessment can help you determine whether it’s best to see a doctor for a hearing aid.
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