Intricon technology to power long-awaited over-the-counter hearing aids
After years of discussion and debate the long-awaited arrival of cheaper, over-the-counter hearing aids is almost here. For one Twin Cities company, it's been a long wait.
Standard hearing aids are typically expensive and not covered by health insurance. Prescriptions won't be required for OTC hearing aids which should be available on the shelf from many retailers. Some 38 million Americans — 15% of adults — report have some trouble hearing. Many people who might benefit from hearing aids previously haven't bothered due to the steep costs. OTC hearing aids could be a game-changer in the world of hearing health.
Arden Hills-based Intricon, which touts expertise in "micromedical technology," is hoping to be a significant player in the OTC hearing aid market.
"In this over-the-counter market I think you're going to see hearing aids priced somewhere between $400 and $600 apiece," said Scott Longval, Intricon's CEO. That would translate into $800 to $1,200 for a pair. The current average cost for a single hearing aid is about $2,300 for one ear.
Longval says that Intricon has focused on assembling the necessary technology, software and firmware which he says has been "almost 10 years in the making." He said that the company wants to help drive "low cost, high quality" hearing aid options. Intricon will produce the hearing aids, but will white label those devices to other companies.
But others have raised consumer concerns about the debut OTC hearing aids. U.S. Rep. Betty McCollum signed onto a letter to the FDA in early April outlining 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 it comes to the diagnosis and treatment of hearing loss," said McCollum in a statement to Star Tribune.
McCollum cautioned that the availability of new OTC hearing aids could create some confusion.
"Over-the-counter hearing aids have the potential to help some individuals with hearing loss. However, people should still seek a professional diagnosis, treatment, and fitting in order to have the best outcome possible to address their unique hearing loss," added McCollum. "If a patient were to improperly use an OTC hearing device, it could have the potential to cause damage or confusion about the solutions available them."
McCollum's concerns echo those from the established hearing-aid industry. OTC hearing aids are intended for adults with mild-to-moderate hearing loss — not for people with more severe hearing issues.
Congress directed the FDA to create a category and regulatory structure for OTC hearing aids in 2017. The original law gave the FDA thee years to draw up regulations but the process has met with several delays, some attributable to the pandemic.
The FDA is currently required to issue its final rule governing OTC hearing aids by July 17, following the issuance of proposed rule in October of last year. The FDA's proposed rule calls for the rule to take effect 60 days after its publication in the Federal Register. Under that schedule, OTC hearing aids could be for sale before the end of the year. But some observers of the serpentine process to date say that further delays are a possibility.
The proposed rule drew more than 1,100 comments, an unusually large amount for proposed regulations. Eden Prairie-based Starkey, a major industry player, weighed in with a 23-page letter outlining a range of concerns.
Starkey floated numerous recommendations for adjustments to the proposed rule including asking the FDA to "require validated labeling to ensure potential users can self-diagnose hearing loss" and "establish a federal level of consumer protection."
"The large manufacturers have pushed back heavily," said Longval
The ListenCarefully web site that addresses the issue is described as a "grassroots advocacy project powered by Starkey."
The site includes a video from Starkey CEO Brandon Sawalich directly addressing President Biden. "At Starkey, we support increased access to hearing health care," said Sawalich in the brief clip. "But as we increase access we must protect patient safety and satisfaction above all else."
It's not yet clear if health insurers will help pay any of the costs for OTC hearing aids. Under federal statute, Medicare does not cover hearing aids or exams for fitting hearing aids. Medicare Advantage plans that are offered by private companies can cover vision, hearing and wellness costs that aren't covered by Medicare. A spokesman for Minnetonka-based Medica said that the insurer had not yet made any decisions about coverage for OTC hearing aids.
One audiologist welcomes the dawn of OTC hearing aids.
"I do 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 puzzled by the array of cheap devices available which are called "hearing aids" but are actually amplifiers.
"It's super confusing to people. Some people think there already are over-the-counter hearing aids," said Oblander. "I think things will get more refined over time. The technology is really going to open up once the FDA labeling gets figured out."
"I think this is on the continuum of what you're seeing in health," Longval said, comparing OTC hearing aids to Warby Parker's impact in the market for eyeglasses. "Eventually this model will be leveraged and be in other regions of the world."
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