MedTech Perspectives | Friday 01 October 2021
New software will strengthen Intricon’s ability to meet consumer demand for retail and online hearing aids
ARDEN HILLS, Minn. – Intricon Corporation (NASDAQ: IIN), a joint manufacturer of micromedical technology development for use in interventional, implantable and body worn medical devices, announced that it has reached a critical milestone in the clinical study of its proprietary software that will allow people to adjust hearing aids themselves, which are sold over the counter in retail stores and online.
Summative usability validation has been completed, demonstrating that users can safely and correctly use Intricon’s self-tuning technology, and that clinical trial of the software can proceed. This step is significant in the progress of the study, which is expected to be completed by the end of 2021, in time for the expected guidelines from the FDA that will allow consumers to purchase and program hearing aids themselves. inexpensively 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 adjust their hearing aids accordingly using a mobile device.
The trial is part of the company’s plan to gain FDA clearance in time to meet expected market demand for over-the-counter hearing aids. President Biden last month ordered the FDA to produce regulations by mid-November for over-the-counter (OTC) hearing aid purchases without a prescription or visiting an audiologist.
In the meantime, new hearing aids have entered state markets, including the HearX Lexie Lumen, now available in some states, which incorporates Intricon hardware, firmware and wireless technology. The Lexie Lumen is sold in Walgreen stores and online for $ 799 per pair, compared to an average of $ 4,800 per pair for hearing aids requiring the assistance of an audiologist.
âAdvanced self-adjusting software will be imperative when hearing aids become available on the mass market,â said Scott Longval, CEO of Intricon, adding that a âcare ecosystemâ must be developed to fully support the consumer experience and success with OTC. hearing aids. This ecosystem includes the right mix of the latest software, hardware, online self-service for equipment and settings, brand partnerships and retail distribution.
âWhile we wait for the FDA to move forward, we continue to advance technology to make over-the-counter hearing aids easy to use for the 3 in 4 people in the United States with mild to moderate hearing loss who do not use hearing aids yet. . ”