The U.S. Food and Drug Administration on Tuesday issued its long-awaited final rule allowing the sale of over-the-counter hearing aids, a move aimed at increasing access and bringing down costs for millions of Americans.
This means consumers will no longer need a prescription to purchase these types of hearing aids that could be available for online and in retail stores by mid-October. The move is expected to increase competition and eventually lower prices.
In Minnesota, medical device manufacturers were split on the news, with long-established hearing aid maker Starkey disappointed by elements of the final rule while other companies such as Intricon Corp., celebrated it.
Nearly 30 million Americans suffer from hearing loss, but only about one-fifth of those people use hearing aids, according to the FDA.
The average cost for a single hearing aid is currently about $2,000, but some can cost as much as $10,000 a pair. These prices, and the lack of insurance coverage, often prevent hearing loss patients from getting hearing aids.
Tuesday's final rule creates a new FDA medical device category for OTC hearings aids aimed at adults with mild or moderate hearing loss. Devices designed for adults with severe hearing loss fall under its prescription category.
President Joe Biden on Tuesday applauded the FDA's decision, saying in a statement the action makes "our economy more competitive and less concentrated."
Peggy Nelson, a professor of audiology at the University of Minnesota, said the industry and researchers have been waiting a long time for this.
"I think we're ready. I think we're excited to have this be a part of the whole package of hearing health care for people who have hearing loss," Nelson said. "We don't know why it has taken so long, honestly."
Arden Hills-based Intricon has spent years developing technology, software and firmware to be used in OTC hearing aids.
"Intricon is really well-positioned to capitalize on this emerging market segment," David Akbari, Intricon's senior medical science, regulatory and clinical affairs liaison, said on Tuesday.
Many of Intricon's OTC hearing aids will be marketed and sold under different brand names. Intricon does not yet have FDA clearance to sell OTC hearing aids, which comes through a specific approval process. The company is now finalizing its submissions to deliver to federal regulators in early September.
"Today, for Intricon, represents the resolution of uncertainty," Akbari said. "This adds clarity and it adds a clear roadmap for our marketing clearances."
Intricon plans to submit three approval requests for different software systems. One for its own Sentibo device and another for a yet-to-be-named OTC hearing aid. It's third submission is for its Lumen 155 OTC hearing aid, which will be sold under different names.
One of its Lumen hearing aids, for instance, would be sold by the HearX Group at a list price of $799 a pair.
Eden Prairie-based Starkey, one of the nation's top hearing aid manufacturers, has raised numerous concerns about the prospect of OTC hearing aids. The company said Tuesday that it is disappointed with aspects of the FDA's final rule.
"As a company that has engineered and manufactured medical devices for over 50 years, we still have concerns with the final OTC rule, including the decision to not include a gain limit and to ignore the concerns of nearly every state's attorney general around preemption and regulation of these devices," said Brandon Sawalich, Starkey's chief executive, in a statement on Tuesday. "Every hearing loss is unique, and the expertise and care of the hearing professional are essential for the best patient outcomes."
"Gain" is an audio term for a device's amplification. It refers to the volume level difference between sound input and output. Under the final rule, federal policy will override state and local exemptions for hearing aids.
The FDA said it took into consideration the public comment it received. In the end, the final rule slightly lowers the allowable decibel output for OTC hearing aids. Sawalich said Starkey is pleased to see that change.
In 2017, Congress directed the FDA to create a category and regulatory structure for OTC hearing aids within three years. But the process had numerous delays, including those caused by the COVID-19 pandemic. The FDA issued its proposed rule in October 2021 that drew more than 1,000 comments.
Nelson, from the University of Minnesota, said that she has some concern about patients' ability to properly fit themselves with OTC hearing aids.
"I think there will be challenges. People will have to figure out how to just take this thing out of the box and make it work," said Nelson.
The FDA's 200-page final rule will be published in the Federal Register on Wednesday, with the rule becoming effective 60 days later.