Neuromod Devices

23/09/2025

Neuromod is proud to announce the receipt of Medical Device Single Audit Program (MDSAP) and EU Medical Device Regulation (MDR) certification for the Lenire Tinnitus Treatment Device.

“Neuromod’s commitment to delivering the highest quality of patient care begins with ensuring our quality management systems are best-in-class,” said Dr. Ross O'Neill, Neuromod Founder & CEO. “MDSAP and MDR certification allows Neuromod to continue expanding Lenire's availability in Europe while positioning the company to commercialize Lenire in new geographies such as Australia, Canada, and beyond.”

In one year, Neuromod has achieved MDSAP certification, MDR approval, Health Canada approval, and TGA approval for the ground breaking tinnitus treatment device, Lenire.

You can read the full coverage over on AudiologyOnline.

Lenire made regulatory history in 2023 by becoming the first and only FDA-approved bimodal neuromodulation tinnitus treatment device.

18/09/2025

“We are already seeing successful outcomes that are helping patients manage tinnitus more effectively.”

Did you know more than 65 million adults in Europe live with tinnitus? That’s millions of people searching for relief every single day.

At Neuromod, we’re expanding the availability of across Europe, partnering with leading hearing care professionals to bring life-changing treatment to more patients.

Neuromod Devices announced 19 new clinical partnerships to expand the availability of the Lenire tinnitus treatment device in Europe

28/04/2025

Lenire Real World Evidence Published. Nature Comms Med has published the 1st analysis of US real world Lenire tinnitus patients.

17/03/2025

Happy St. Patrick’s Day to all our friends, family and colleagues from Neuromod Devices.

As an Irish company, today is a special day to celebrate our heritage, innovation, and the global community we’re proud to be part of. Whether you're at home or abroad, we hope your day is filled with joy, luck, and a touch of Irish magic ☘️

11/03/2025

Irish Examiner coverage of Neuromod Devices closing €10m financing to further expand availability of Lenire Tinnitus Treatment Device. 2.9 million US Veterans live with tinnitus.

Neuromod is working with U.S. Department of Veterans Affairs and other US Government services to increase Veteran access to Lenire, the only FDA Approved bimodal tinnitus treatment device.

Neuromod has closed a €10m round of equity financing as it looks to expand the availability of its tinnitus treatment device

11/03/2025

Neuromod Devices has today announced the company has closed €10m financing to accelerate commercialisation, and availability of Lenire Tinnitus Treatment Device. Financing led by existing investors Fountain Healthcare Partners and Panakes Partners.

“We are delighted to announce an oversubscribed financing at a pivotal time when we are driving forward with our mission of making Neuromod the category creator for tinnitus globally,” said Dr. Ross O’Neill PhD, Founder & CEO of Neuromod.

Neuromod Devices is an ambitious, forward-looking medical technology company formed to advance the science of neuromodulation, we named ourselves Neuromod in the shared belief of what this cutting edge branch of medicine can achieve.

22/10/2024

Don't miss Session One of the The Tinnitus Collaborative's Virtual Sessions 2024, starting at 4PM (EST) on Tuesday, Oct. 22 — https://shorturl.at/jplWC

Dr. Craig Kasper Au. D. will discussing Bimodal Neuromodulation for Tinnitus: Real-World Clinical Outcomes of Lenire, and Dr. Rachael Cook, Au.D. will dive into Biometric Tracking & Personalized Care of Tinnitus Patients.

Register for The Tinnitus Collaborative Virtual Sessions: Session One for an exciting look at the future of tinnitus care with leading tinnitus experts.

11/09/2024

"Expect bimodal neuromodulation to be one of the most popular forms of treatment..."

Check out Doctor Cliff AuD's video about the results of the TENT-A3 controlled clinical trial of Lenire Tinnitus Treatment Device.

TENT-A3's results were pivotal in Lenire becoming the first and only bimodal neuromodulation device approved for the treatment of tinnitus by the US FDA.

Dr. Olson discusses:
- How the TENT-A3 trial was designed and controlled
- The importance of evidence for tinnitus treatment
- The significance of Lenire's benefit for people living with tinnitus

Educating consumers about hearing loss and treatment options.

31/07/2024

Mark Van Oirschot was struggling with severe tinnitus until Lenire gave him relief from chronic tinnitus. Read his inspiring story.

26/07/2024

Neuromod Devices Chief Scientific Officer, Prof. Hubert Lim joined Dr. Cliff Olson on the Dr. Cliff Show to deep-dive into the clinical research behind Lenire Tinnitus Treatment Device, the first and only tinnitus treatment device of its kind.

"One of the things that I hope is, that there is a positive, collaborative spirit with the goal of pushing advancements in tinnitus treatments forward." Prof. Hubert Lim.

https://youtu.be/hZw2E0zpn7M?si=hUhJN-nvHLk77SAe

Lenire Tinnitus Device | Interview with Dr. Hubert Lim Chief Science Officer of Neuromod | The Dr. Cliff Show. Discussing the Research behind the Lenire Ti...

04/07/2024

Happy 4th of July to all of our friends, colleagues, partners and those living with tinnitus in the United States of America from everyone at Neuromod Devices.

Remember! If you're celebrating the 4th of July with fireworks or in noisy environments, be sure to wear hearing protection.

19/06/2024

"I feel like a success just not to be so bothered by it all the time,= - Lenire Tinnitus Treatment Device patient Jeff Matchan speaking to Reuters about

An FDA-approved device called Lenire can help treat tinnitus by training the human brain to ignore the ear ringing. Alice Rizzo has more.