Tuned AI-Driven App for OTC Hearing Aids Gains FDA 510K Approval, Paves Way for Future Self-Fitting Devices

Tuned™, a patented self-fitting application for over-the-counter (OTC) hearing aids powered by artificial intelligence (AI), has received 510k FDA Class II clearance. Partnering with hearing aid developer and manufacturer Intricon, Tuned’s self-fitting app will first be employed in the Intrisound™ Tuned Lumen^® 155 hearing aid.

The newly approved app-powered hearing aid solution is said to combine audiology and psychology to enhance user engagement, motivation, and education, optimizing the efficacy of their hearing aid experience while minimizing product-related issues and service costs. This AI technology will be integrated into OTC hearing aids, offering opportunities for private branding and retail and online sales. Moreover, AI plays a central role in Tuned's teleaudiology platform, providing clinicians with a comprehensive framework to assist customers from onboarding through usage while also monitoring and analyzing their progress.

Using the Tuned smartphone app, users can access guided hearing tests for personalized adjustments, coaching, and positive reinforcement. Customer support is delivered via an advanced chatbot interface called the self-service Hearing Assistant, and a remote support platform can connect clinicians with users via the app, reducing the need for in-person visits and call center interactions.

“We think Tuned will revolutionize hearing aids by supporting customers through the entire rehabilitation process using advanced AI technology,” Tuned CEO Omri Gavish told HearingTracker in a phone interview while at an AgeTech conference sponsored by AARP, an organization that has also partnered with Tuned. “AI is used during the hearing aid fitting and throughout the entire rehabilitation and wearing experience. It’s designed to walk customers through the process—from beginning to end—and help them acclimate and effectively accept and use their hearing aids.

“It’s a full system designed to encompass everything needed for hearing aid acceptance, so the customer gets used to and can benefit from the devices,” continues Gavish. “We know that hearing is not a simple linear sense; compensating for hearing loss with hearing aids is not like compensating for vision loss with glasses—overcoming hearing loss with hearing aids is a much more involved process. Our system is designed with built-in capabilities for engagement, adjustments, coaching, interaction, and positive feedback—providing the needed support for motivating and satisfying the customer’s unique hearing aid needs.”

The Tuned solution also features a robust Customer Relationship Management (CRM) platform, empowering providers to maintain detailed patient histories, anticipate future needs, and make informed business decisions while fostering enduring patient connections.

The new app will work with both iOS and Android smartphones. Tuned and Intricon are developing a product roadmap with interested partners that includes global brands.

Tuned turns to AI technology for a better OTC hearing aid experience

Tuned, with headquarters near Tel Aviv, was founded in 2020 by Gavish and CTO Ron Ganot. (The company is not affiliated with the US-based employee-benefit provider TunedCare.)  Gavish is a lawyer with extensive commercial and sales experience, and Ganot is an audiologist who headed up the audiology engineering department at the Clalit Group in Israel. Together, they had previously founded a successful hearing products distribution company called AudioCare. Tuned also gains considerable direction from its Chair, Amit Ben, an investor with deep experience in AI self-service: he was cofounder of Nano Rep AI, which was acquired by LogMeIn, where he also served as head of AI.

Intricon has been manufacturing hearing aids for over four decades and is a respected developer of amplification technology and medical micro-electronics. It is perhaps the most prominent “white-label” US manufacturer of hearing aids and owns the online hearing aid distributor Hearing Help Express.

AI-driven hearing aid self-fitting and sound acclimation process

Gavish says the Tuned setup and subsequent acclimation process is unique in that everything is done as if the customer were in a hearing clinic. The company has devised a way to pair the devices without the need to go to the device settings; the wireless pairing of the hearing aid and smartphone can be done from the app itself. This should be especially handy for an aged user who may not be adept at finding and manipulating menus on a cell phone.

“Our data shows that more than 95% of people using our application could pair the devices correctly by themselves without anyone needing to help them,” says Gavish. “For this study, we put them in a room with the devices and the application, and we instructed them using step-by-step videos that explain exactly how to set up the device. These videos show them everything in a very unique way to differentiate between the left device and right device, and we also validate with our software if the user is wearing them correctly.”

The smartphone app provides a guided self-administered hearing test to tune the hearing aids based on the user’s personal hearing profile. Gavish says the verification of the fittings using the Tuned fitting software in their studies resulted in less than a 5 dB difference from what was achieved by in-clinic professionals.

First-time users of hearing aids frequently find amplified sounds too loud or annoying, resulting in the hearing aid being returned before actually giving it a real chance. That’s why professional hearing aid fittings often employ an “acclimation period” where users are eased into a full-volume prescriptive fit over time. Similarly, the Tuned acclimatization process also involves not starting at the 100% prescribed volume (gain) but instead increases gain gradually via the AI’s analysis of specific user parameters that are recorded in the application’s data-logging system. Gavish contends this should lead to better acclimation and result in greater numbers of users sticking with the device.

Support chatbot for challenging listening situations and gamified learning

The AI system also adjusts the sound parameters, helping to resolve problems in more challenging listening situations. “Within the application, we use a support chatbot as a smart interface, utilizing a GPT [Generative Pre-training Transformer, a form of AI] technology developed by Tuned,” says Gavish. “We trained it with more than 40 years of audiology experience using recordings of natural language describing hearing problems. The AI can understand the problem from a natural language and then calibrate the parameters of the hearing aids, providing a solution for the user’s hearing difficulty.”

The Tuned system also uses coaching and gamified instruction for people interested in learning how to use their hearing aids more effectively. As people progress through the program, they earn digital badges. Although Tuned does not currently have a rewards program, he thinks this may be a future possibility for hearing aids that employ the Tuned app. The objective is to provide continuous positive feedback throughout the rehabilitation process.

Down on OTC hearing aids? You ain’t seen nothing yet, says Intricon

October 17 marks the 1-year mark of OTC hearing aids being available, and some have expressed disappointment in consumers’ acceptance of these new devices. Designed to increase affordability and access to people with hearing loss, OTC aids made up less than 1% of traditional hearing aid manufacturers’ sales in the first quarter of 2023 according to Hearing Industries Association (HIA) statistics. A survey from the American Speech Language Hearing Association (ASHA) this week indicated that just 2% of respondents aged 40+ with hearing difficulties said they had purchased an OTC hearing device, and only 4% said they were likely to buy one in the next year.

This is understandable, according to Delain Wright, Intricon’s Head of Business Development-Hearing. “Over-the-counter hearing aids are a brand-new product category, and it will take some time to get established. Most current OTC products don’t fit what was originally envisioned for this market.” He says most name-brand manufacturers’ OTC designs resemble prescriptive devices and are offered at prices above $800—which is too pricey for the majority of people seeking an inexpensive solution for their mild-to-moderate hearing loss.

“I really believe that the so-called ‘failure of OTC’ is being pronounced way too early by the industry and the existing traditional stakeholders,” continues Wright. “We're just starting. You need to get the right products at the right prices to the right people—and an intuitive, easy-to-use software interface is vital to the success of these products. We won't know how successful OTC can be until this happens. And I believe it's in the best interest of hearing care professionals to stay in the middle of all this and integrate OTC products into a complete range of hearing solutions that includes assistive devices, hearing protection, and specialized services for all age ranges and hearing-related needs.”

Wright says the Tuned technology is turning heads with its tremendous opportunity for multiple markets in global hearing healthcare, including professional dispensing, mass retail, online, and insurance. He says partnerships using the Tuned technology are on the horizon with some major established brands that will bolster this nascent product class. He told HearingTracker, “In terms of OTC hearing aids, I think ‘you ain’t seen nothing yet.’”