Clinical Trial Results
June 15, 2022
Intricon Sentibo technology is first psychoacoustic-based hearing aid with audio that can be self-fit by its user, setting new standards for the hearing aid industry
ARDEN HILLS, Minn. (June 15, 2022) – Intricon, a micromedical technology company that makes interventional, implantable, and body-worn medical devices, has announced the results of a clinical trial studying its new Sentibo self-fitting hearing aid technology. The study compared the sound quality, fitting process, and overall benefits of hearing aids that were self-programmed using the Sentibo mobile app to hearing aids programmed by a hearing care professional. The study concluded users were, on average, more satisfied with the self-fitting hearing aid. Intricon commissioned the study to prove satisfaction, quality, and safety of its proprietary self-fitting technology, in time for the FDA decision that will allow hearing aids to be sold over the counter (OTC).
The Sentibo self-fit method, which uses a proprietary psychoacoustic audibility model, is the first to not rely on the National Acoustic Laboratory (NAL-NL2) prescriptive fitting method. Audio is self-fit by the wearer.
“We commissioned the study to make sure people will have an equal if not better experience with over-the-counter hearing aids than traditional prescription hearing aids. At the same time, we wanted to evolve the industry and its traditional fitting standards that have existed for years,” said Scott Longval, CEO of Intricon. “We view OTC hearing aids as an opportunity for the industry to take a major step forward, and we want to be a leader in taking it into the future.”
Intricon studied the NAL-NL2 audibility model, common in the industry since 2011, to identify opportunities for new advancements, such as using a psychoacoustic audibility model during self-fitting for people with varying fidelity expectations to identify their unique needs, with a wider dynamic range of sound. Because psychoacoustic audibility focuses on the user’s perception of sound, it helps everyone hear at a level that is optimized for their unique perception to not miss certain sounds, regardless of their hearing sensitivity.
“Sounds have never been combined in this way before,” explains Longval. “Sentibo is truly precedent-setting in all aspects of the hearing aid customer experience.”
Longval adds that Intricon’s goal in developing technology for OTC hearing aids is to improve access and affordability for the 38 million people in the U.S. with mild to moderate hearing loss. Intricon provides components and technology for hearing aids that are professionally fit and self-fit, such as the commercially marketed Lumen 155 hearing aid used in the study.
“For 45 years, Intricon advancements have been focused on expanding the hearing aid market and giving people more options,” said Longval.
About Intricon Corporation
Intricon is a Joint Development Manufacturer that integrates micromedical components and assemblies to advance technology across a range of medical 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.