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 press@tuned.in.

November 14, 2022

David Akbari
Left to Right: Dr. Victor Bray, Dr. David Akbari, Dr. Alicia Spoor

Intricon’s Dr. David Akbari Receives Prestigious Hearing Industry Leadership Award

The Academy of Doctors of Audiology (ADA), a leading national audiology association, selected David Akbari, Au.D., senior medical science, clinical, and regulatory affairs liaison at Intricon, to receive its prestigious annual ADA Hearing Industry Leadership Award for 2022. The award recognizes an individual or organization for outstanding achievements that elevate or advance the hearing industry. Dr. Akbari was recognized at the 2022 ADA AuDacity Conference in Dallas in October.

Dr. Akbari is the first and only individual to win the award. The 2022 award is significant in that the ADA has not given an award in the past 10 years, and it does not take nominations for the award.

The ADA chose Dr. Akbari because of his vision for and significant contributions to the hearing health industry throughout his career. One of those contributions included serving as a member of the ADA Over the Counter (OTC) Hearing Aid Working Group, through which Dr. Akbari provided invaluable technical and scientific expertise to help formulate the ADA’s recommendations to the U.S. Food and Drug Administration (FDA) in response to its Proposed Rule Establishing Over the Counter Hearing Aids, many of which were adopted by the agency.

The FDA ruling on OTC hearing aids was passed and, on October 17, 2022, for the first time, adults with mild to moderate hearing loss in the U.S. were able to buy hearing aids at retailers and online, without a prescription. The development will provide greater access to hearing aids for millions of people.

Dr. Akbari is a national authority on hearing health and leader at Intricon, which has a 45-year legacy of improving people’s lives with sensor-enabled micromedical devices.  

News Release: https://audiologist.org/resources/communications/in-the-news/item/dr-david-akbari-receives-prestigious-ada-hearing-industry-leadership-award

October 6, 2022

Dr. Akbari discusses his predictions on the impact of the recent FDA ruling

This comprehensive podcast, produced by The Hearing Journal, the premier publication for hearing health professionals, features Intricon’s senior medical science, clinical, and regulatory affairs liaison, Dr. David Akbari. Dr. Akbari discusses his predictions on the impact of the recent FDA ruling that allows hearing aids to be sold over the counter, without the need for an audiologist.

The FDA decision ends five years of commentary and speculation on how OTC hearing aids will impact on people with mild to moderate hearing loss and hearing health practitioners.

The podcast is part of a four-part series examining the game-changing transformation of the industry. In this episode, Dr. Akbari and other guests review the FDA OTC rule and:

Dr. Akbari has been very active in hearing health industry professional associations involved in setting standards for objective measurement of quality and performance of OTC hearing aids.

The podcast is available at https://journals.lww.com/thehearingjournal/pages/podcastepisodes.aspx?podcastid=4 and on Stitcher, Apple podcasts, and Spotify.


July 7, 2022

This Week in Hearing Webcast features Dr. David Akbari, Intricon’s Senior Medical Science, Clinical, and Regulatory Affairs Liaison

Intricon’s resident audiologist, Dr. David Akrabi, was recently interviewed by Dr. Amyn Amlani of Hearing Health and Technology Matters media for a This Week in Hearing webcast. Dr. Akbari was asked to share more about a recent study that examined the performance of Intricon’s Sentibo self-fit hearing aid audio technology to professionally fit hearing aids. The study compared sound quality, fitting process, and overall benefits of the two hearing aids, each with different fitting approaches.

Intricon commissioned the study to measure a minimum of non-inferiority of the self-fit to the pro-fit, yet findings revealed that satisfaction and experience of the self-fitting technology ranked higher than the professionally fit model.

The webcast discussion also covers how the Sentibo self-fit method uses a proprietary psychoacoustic audibility model vs. the standard National Acoustic Laboratory (NAL-NL2) prescriptive fitting method.

Drs. Akrabi and Amlani discuss the state of the hearing aid industry and the impending OTC market, which will provide more accessible and affordable quality hearing aids to millions of people with mild to moderate hearing loss. They predict that products and service delivery models will be enhanced when hearing aids become available over the counter.

Sentibo, which is already used in Germany and is currently awaiting regulatory clearance, was designed by Intricon with human factors in mind — to make complex technology as simple to use as possible.

“Meeting patients where they are and empowering them is the future of hearing health,” said Dr. Amlani.

Click here to listen to the webcast: https://anchor.fm/thisweekinhearing/episodes/071—Comparing-Self-Fit-Hearing-Aids-to-Professionally-Fit-Devices-Intricons-Clinical-Trial-e1krnj5/a-a87a8fr

Clinical trial Update

October 21, 2021

Great news! Check Hearing Health Matters: “Intricon Self-Fitting Technology for OTC Hearing Aids Clears Clinical Trial Milestone, an important step towards mass market availability. Visit: https://hearinghealthmatters.org/blog/2021/intricon-self-fit-otc-hearing-aids-trial/.

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.

The Intricon Story that Earned the Company a 2022 Manufacturer of the Year Award

The Minneapolis St. Paul Business Journal tells the story of why Intricon is being recognized with its 2022 Manufacturer of the Year Award, in an interview with CEO Scott Longval.

Scott discusses Intricon’s record year in 2021 and the additional growth expected in 2022. Much of Intricon’s success is a result of the healthcare industry’s focus on minimally and non-invasive procedures, that require advanced micromedical innovation from Intricon. In 2022, the company, with its roots in hearing aid technology, is also expected to benefit from being a major supplier in the hearing aid industry when over-the-counter (OTC) hearing aids become available to the American public, a market projected to exceed $11 billion by 2028.

“I’m proud to say that our job is to extend, improve and save lives,” said Scott.

The Manufacturer of the Year Awards recognize manufacturing companies that drive the Upper Midwest’s economy and leaders in the manufacturing industry who are growing their businesses.

Intricon was founded in Minnesota, the heart of the Medical Alley region of healthcare and med device innovation, in 1977 and now has 800-plus employees across three offices and six manufacturing sites in Minnesota, California, Singapore, and Indonesia.

The full story is here.

Intricon Featured in Star Tribune

June 1, 2022

Intricon Featured in June 1, 2022 Star Tribune Business Section

Intricon Technology To Support OTC Hearing Market

Millions of Americans who need top quality, more affordable and accessible hearing aids will soon have more options; our CEO Scott Longval shares his perspective in today’s Star Tribune. For 45 years, we’ve provided technology and manufacturing for hearing aids from audiologists. Now we’re excited our contributions to advanced hearing aids will soon be available over the counter too, including new self-fitting technology.

Read Article Here:


Intricon Featured on Medical Alley Podcast

Founder Mark Gorder and CEO Scott Longval join Medical Alley for a discussion on Intricon’s history and future

Intricon founder Mark Gorder and president and CEO Scott Longval joined Frank Jaskulki, vice president of intelligence at Medical Alley, for a podcasted discussion on Intricon’s 45-year legacy in the micromedical industry and the future of the company.

Medical Alley is The Global Epicenter of Health Innovation and Care®, a place that healthcare leaders call home. The Medical Alley Association is a community of these leaders, who represent the world’s highest concentration of top innovation and healthcare companies. Minnesota, where Intricon is based, is at the heart of Medical Alley. The Medical Alley region is home to the nation’s largest private health insurer and more than 1,000 med device and healthcare companies, employing millions of people worldwide. Medical Alley has history, as the birthplace of implantable medical technology, collaborative care delivery, and innovative health plan models. The Smithsonian has recognized six “Great Places of Invention” in the U.S., including only one for healthcare: Medical Alley.

Intricon is a key part of both the history and the future of this ecosystem. The company designs, develops, manufactures, and even packages microminiature components for companies worldwide. It is a pioneer in micromedical med devices.

Hear more about the Intricon story by listening to the Medical Alley podcast here.