After years of discussion and debate, the long-awaited arrival of cheaper, over-the-counter hearing aids is almost here. For a Twin Cities company, the wait has been long.
Standard hearing aids are usually expensive and not covered by health insurance. Prescriptions won’t be needed for over-the-counter hearing aids that should be available on the shelves of many retailers. Some 38 million Americans – 15% of adults – report having hearing problems. Many people who could benefit from hearing aids before haven’t bothered because of the high costs. Over-the-counter hearing aids could be a game-changer in the world of hearing health.
Arden Hills-based Intricon, which touts its expertise in “micromedical technology”, hopes to be a big player in the over-the-counter hearing aid market.
“In this over-the-counter market, I think you’re going to see hearing aids that are priced between $400 and $600 each,” said Scott Longval, CEO of Intricon. This would translate to $800 to $1,200 for a pair. The current average cost for a single hearing aid is around $2,300 for one ear.
Longval says Intricon focused on putting together the necessary technology, software and firmware, which he says took “almost 10 years to develop.” He said the company wanted to help promote “low-cost, high-quality” hearing aid options. Intricon will produce the hearing aids, but will white label these devices to other companies.
But others have raised concerns among consumers about the first over-the-counter hearing aids. US Representative Betty McCollum signed a letter to the FDA in early April outlining her concerns.
“I have a family history of hearing loss and have worked with the Deaf and hard of hearing communities over the years. I know firsthand the importance of personalized care when diagnosing and treating hearing loss,” McCollum said. in a statement to Star Tribune.
McCollum warned that the availability of new over-the-counter hearing aids could create some confusion.
“Over-the-counter hearing aids have the potential to help some people with hearing loss. However, people should always seek professional diagnosis, treatment and fitting to get the best possible outcome for their unique hearing loss. “, added McCollum. “If a patient were to use an over-the-counter hearing aid inappropriately, it could have the potential to cause harm or confusion about the solutions available to them.”
McCollum’s concerns echo those of the established hearing aid industry. OTC hearing aids are intended for adults with mild to moderate hearing loss, not people with more severe hearing problems.
Congress directed the FDA to create a category and regulatory structure for over-the-counter hearing aids in 2017. The original law gave the FDA three years to develop regulations, but the process has encountered several delays, some attributable to the pandemic.
The FDA is currently required to release its final rule governing over-the-counter hearing aids by July 17, following the publication of the proposed rule in October of last year. The rule proposed by the FDA provides that the rule takes effect 60 days after its publication in the Federal Register. According to this schedule, over-the-counter hearing aids could be on sale before the end of the year. But some observers of the serpentine process so far say further delays are a possibility.
The proposed rule drew more than 1,100 comments, an unusually high amount for proposed regulations. Eden Prairie-based Starkey, a major player in the industry, weighed in with a 23-page letter outlining a range of concerns.
Starkey issued numerous recommendations for adjustments to the proposed rule, including asking the FDA to “require validated labeling to ensure that potential users can self-diagnose hearing loss” and “to establish a federal level of consumer protection”.
“The big manufacturers have pushed back heavily,” says Longval
The ListenCarefully website which addresses the issue is described as a “starkey-powered grassroots advocacy project”.
The site includes a video of Starkey CEO Brandon Sawalich speaking directly to President Biden. “At Starkey, we support increased access to hearing healthcare,” Sawalich said in the brief clip. “But as we increase access, we must protect patient safety and satisfaction above all else.”
It’s not yet clear whether health insurers will help pay for the costs of over-the-counter hearing aids. Under federal law, Medicare does not cover hearing aids or hearing aid fitting exams. Medicare Advantage plans offered by private companies may cover vision, hearing, and wellness costs that are not covered by Medicare. A spokesperson for Minnetonka-based Medica said the insurer has not yet made a decision about over-the-counter hearing aid coverage.
An audiologist hails the advent of over-the-counter hearing aids.
“I support the concept. I think it will help increase patient access,” said Dr. Melisa Oblander, director of audiology for M Health Fairview.
But she acknowledges that many consumers are already intrigued by the range of inexpensive devices available that are called “hearing aids” but are actually amplifiers.
“It’s super confusing for people. Some people think there are over-the-counter hearing aids out there already,” Oblander said. “I think things will refine over time. The technology will really open up once FDA labeling is understood.”
“I think it’s part of the continuum of what you see in health,” Longval said, comparing over-the-counter hearing aids to Warby Parker’s impact on the eyewear market. “Eventually this model will be taken to advantage and will be in other parts of the world.”