TUNED ANNOUNCES 510K FDA CLEARANCE FOR SELF-FITTING HEARING AID TECHNOLOGY
New York, New York (Sept. 13, 2023) – Hearing aid technology company Tuned announces the 510k FDA clearance of its new class II self-fitting, self-adjusting hearing aid technology. The technology will be used in the Intrisound™ Tuned Lumen® 155 Hearing Aids, developed and manufactured by Intricon.
“We’re redefining hearing care, making it accessible and affordable for everyone,” said Omri Gavish, CEO at Tuned. The company partnered with Intricon, which has more than four decades of experience bringing advanced hearing aids to market, to provide the hardware expertise for the finished product.
The newly approved app-powered hearing aid solution engages, motivates, and educates users, maximizing the benefits of their hearing rehabilitation journeys. The technology integrates audiology and psychology to elevate user satisfaction and adoption rates while minimizing product issues and lowering service costs. The technology will be featured in over-the-counter (OTC) hearing aids, able to be privately branded and sold at retail stories and online. Additionally, it is a key component of Tuned’s innovative teleaudiology platform, which provides hearing healthcare providers with a comprehensive framework to support customers throughout their onboarding and usage, all the while tracking and analyzing their progress.
The self-service experience for hearing aids featuring the new Tuned technology is powered by a smartphone app through which users access guided hearing tests that enable them to personalize their hearing aid to align perfectly with their individual hearing needs. Customer support is provided by an advanced chat interface — the self-service Hearing Assistant — and through a remote support platform that allows hearing care professionals to remotely connect to users through the app, reducing in-person visits and call center interactions. The Tuned solution also includes a comprehensive Customer Relationship Management (CRM) platform designed to empower providers to strengthen patient connection and support throughout their lifetime of hearing needs. The CRM provides patient data, enabling care professionals to maintain detailed histories of their patients’ experiences, anticipate and plan for future needs, and inform decisions for their businesses.
For more information about hearing aids featuring Tuned technology, visit Tuned.in or email email@example.com.