Intricon Applauds FDA's Proposal to Improve Access to Hearing Aid Technology for Millions of Americans, Paving the Way for Over-the-Counter Hearing Aids
OTC Hearing Aid Act designed to offer greater public access to hearing aids at a lower cost
Commenting on the FDA’s proposal,
“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
Under the draft guidance, a new regulatory category would be established for OTC hearing aids intended for Americans 18 years or older and suffering from self-perceived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The FDA has now opened the draft guidance for a 90-day public comment period, with a final rule becoming effective 60 days after the final rule is published.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.
Source: Intricon Corporation