Intricon Corporation (NASDAQ: IIN), a joint development manufacturer of micromedical technology for use in interventional, implantable, and body-worn medical devices, announced that it has achieved a “critical milestone in the clinical study of its proprietary software that will allow people to self-fit hearing aids that are sold over-the-counter at retail stores and online.”
Summative Usability Validation has been completed, which helps demonstrate that users can “safely and correctly use the Intricon self-fitting technology,” and the clinical trial of the software can move forward. According to the company, the milestone is meaningful in the progression of the study, which is expected to be complete by the end of 2021, in time for the anticipated FDA guidance that will allow consumers to purchase and program hearing aids themselves, at a lower cost and without the need for an audiologist.
The study is being conducted by Intricon research partner clEAR/Amptify, involving 120 participants with mild-to-moderate hearing loss. The software will allow consumers to test their hearing and set their hearing aids accordingly using a mobile device.
The trial is part of the company’s plan to secure FDA clearance in time to meet the expected market demand for over-the-counter hearing aids. Last month, President Biden ordered the FDA to produce regulations by mid-November for over-the-counter (OTC) purchases of hearing aids without a prescription or a visit to an audiologist.
In the meantime, new hearing devices have entered state markets, including the HearX Lexie Lumen, now in selected states, that features Intricon hardware, firmware, and wireless technology. The Lexie Lumen is sold in Walgreen’s stores and online for $799 per pair.
“Advanced self-fitting software will be imperative for when hearing aids are available to the mass market,” said Scott Longval, CEO of Intricon, adding that an “ecosystem of care” must be developed to fully support the consumer experience and success with OTC hearing aids. This ecosystem includes the right combination of the latest software, hardware, online self-service for fittings and settings, partnerships for branding, and retail distribution.
“While we wait for the FDA to move forward, we’re continuing to advance the technology to make OTC hearing aids easy to use for the 3 out of 4 people in the US with mild-to-moderate hearing loss who are not yet using hearing devices.”