Intricon applauds FDA proposal to improve access to hearing aids …

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MedTech Perspectives | Friday, October 22, 2021

OTC Hearing Aid Act designed to provide better public access to hearing aids at lower cost

Intricon is well positioned to provide the necessary ecosystem to deliver high customer satisfaction

ARDEN HILLS, Minn. – Intricon Corporation (NASDAQ: IIN), a manufacturer of joint development of micromedical technology for use in interventional, implantable, and body worn medical devices, strongly supports the US Food and Drug Administration (FDA) proposal aimed at improving access and lowering the cost of hearing aid technology for millions of Americans. On October 19, 2021, the FDA proposed a rule to establish a new regulatory class 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 review. medical. or fitting by an authorized person, such as an audiologist.

Commenting on the FDA proposal, Scott Longval, CEO of Intricon, said: “The FDA proposal to provide better public access to hearing aids at lower cost is an important step towards more widespread hearing health, by removing the significant obstacles existing today that prevent innovative solutions. We have long supported opening this market to the substantial number of Americans with mild to moderate hearing loss who previously could not get a prescription, could not justify the cost, or could not afford. prescription hearing aids. . “

“We are very optimistic about the approval of this proposal and look forward to expanding our partnerships with market players who can benefit from our hardware, firmware, software and back-end support,” added Longval.

Nearly 30 million Americans suffer from age-related hearing loss, including more than half of adults aged 70 to 79. Yet only a small portion of Americans with hearing loss (about 20%) use hearing aids, mainly because of their high cost. Hearing aids are not covered by Medicare or most private insurance plans, and out-of-pocket expenses for a single hearing aid average $ 2,400, and 70% suffer loss hearing in both ears, increasing costs to an average of $ 4,800, which is far from the case. reach many consumers.

According to the draft guidance, a new regulatory category would be established for over-the-counter hearing aids intended for Americans 18 years of age or older with self-perceived mild to moderate hearing loss, offering a significantly less expensive alternative to channels. distribution systems that require a visit to the audiologist’s office. The draft regulation proposes maximum output levels of 115 dB SPL to 120 dB SPL, which will meet the needs of the vast majority of hearing impaired people while ensuring the safety of consumers. In addition, the proposal would allow consumers to adjust and adjust their hearing aids themselves without the help of an audiologist.

“Pending the final decision, we remain committed to advancing our position in the hearing health ‘ecosystem of care’ to fully support the consumer experience and success with over-the-counter hearing aids. This includes advancing our technology, securing distribution partners, continuing to support pilot programs, and completing our self-adaptation software clinical trial, ”concluded Longval.

The FDA has now opened the draft guidelines for a 90-day public comment period, with a final rule taking effect 60 days after the final rule is released. The FDA proposal can be viewed at www.federalregister.gov/d/2021-22473.


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