Intricon Applauds FDA’s Proposal to Improve Access to
OTC Hearing Aid Act designed to offer greater public access to hearing aids at a lower cost
Intricon well positioned to provide the ecosystem necessary to deliver high customer satisfaction
ARDEN HILLS, Minn., Oct. 20, 2021 (GLOBE NEWSWIRE) — Intricon Corporation (NASDAQ: IIN), a joint development manufacturer of micromedical technology for use in interventional, implantable, and body-worn medical devices, strongly supports the U.S. Food and Drug Administration (FDA) proposal to improve access to and reduce the cost of hearing aid technology for millions of Americans. On October 19, 2021, the FDA proposed a rule to establish a new regulatory category of over-the-counter (OTC) hearing aids that when finalized, would allow hearing aids to be sold directly to consumers in stores or online without a medical exam or a fitting by a licensed person, such as an audiologist.
Commenting on the FDA’s proposal, Scott Longval, CEO of Intricon, said, “The FDA’s proposal to provide greater public access to hearing aids at a lower cost is an important step forward in more widespread hearing health, removing the significant barriers existing today that prevent innovative solutions. We have long been in support of opening this market to the substantial number of Americans suffering from self-perceived mild-to-moderate hearing loss who previously could either not obtain a prescription, could not justify the cost, or could not afford prescription hearing aids.”
“We are very optimistic that this proposal will be approved and look forward to expanding our partnerships with market participants that can benefit from our hardware, firmware, software and back-end support,” added Longval.
Nearly 30 million Americans experience age-related hearing loss, including over half of adults between the ages of 70 to 79. Yet only a small share of Americans with hearing loss—approximately 20 percent—use hearing aids, primarily due to their high cost. Hearing aids are not covered by Medicare or most private insurance plans, and out-of-pocket costs for a single hearing aid average $2,400, and 70 percent suffer hearing loss in both ears, increasing costs to, on average, $4,800—far out of reach for many consumers.
Under the draft guidance, a new regulatory category would be established for OTC hearing aids intended for Americans 18 years or older and suffering from self-perceived mild-to-moderate hearing loss, providing a significantly less expensive alternative to contemporary distribution channels that require an audiologist office visit. The draft regulation proposes maximum output levels from 115 dB SPL up to 120 dB SPL, which will meet the needs of the vast majority of hearing impaired while ensuring consumer safety. Additionally, the proposal would allow consumers to self-fit and self-adjust their hearing aids without engaging an audiologist.
“While we await the final ruling, we remain committed to advancing our position in the hearing health ‘ecosystem of care’ to fully support the consumer experience and success with OTC hearing aids. This includes further advancing our technology, securing distribution partners, continuing to support pilot programs, and completing our self-fitting software clinical trial,” Longval concluded.
The FDA has now opened the draft guidance for a 90-day public comment period, with a final rule becoming effective 60 days after the final rule is published. The FDA proposal can be found at www.federalregister.gov/d/2021-22473.
About Intricon Corporation
Intricon is a Joint Development Manufacturer that integrates micromedical components and assemblies to advance technology across a range of device platforms for global customers. Intricon approaches each engagement with an all-in commitment, working with customers every step of the way – from the earliest idea stages to ongoing production – in order to advance program performance and deliver results. With a focus on key device platforms, Intricon helps advance clinical outcomes by always looking ahead with proactive support and resources through integration of its core competencies. Intricon has facilities in the United States, Asia and Europe. The company’s common stock trades under the symbol “IIN” on the NASDAQ Global Market.