Neuromod Devices

Neuromod Devices Neuromod has developed a revolutionary bimodal neuromodulation treatment for chronic tinnitus, a con

Neuromod is proud to announce the receipt of Medical Device Single Audit Program (MDSAP) and EU Medical Device Regulatio...
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.

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

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Rainsford Street
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