Summary:
Neuromod Devices has achieved both Medical Device Single Audit Program (MDSAP) and EU Medical Device Regulation (MDR) certification, enabling expanded global availability of its Lenire tinnitus treatment device in Europe, Canada, Australia, and beyond.

Key Takeaways:

  • Global Expansion: MDSAP certification and subsequent approvals from Health Canada and Australia’s TGA allow Lenire to enter new international markets.
  • High Regulatory Standards: MDR compliance ensures Lenire meets Europe’s enhanced safety and quality requirements, maintaining EU availability and supporting future development.
  • Tinnitus Solution: These approvals reinforce Lenire’s status as a rigorously tested, clinically validated tinnitus treatment, following its 2023 U.S. FDA De Novo authorization.

Neuromod Devices, the medical device company that created the Lenire tinnitus treatment device, has announced approval to the Medical Device Single Audit Program (MDSAP) and EU Medical Device Regulation (MDR) certification.

Neuromod’s MDSAP certification comes following a comprehensive audit verifying compliance with the international standard ISO13485 and specific regulatory requirements in multiple regulatory jurisdictions including Canada (Health Canada) and Australia (TGA).

Following MDSAP certification Neuromod secured both Health Canada and TGA approval to place Lenire on the market in those territories.

Tinnitus, which is commonly known as ringing in the ears, is a complex neurological condition that affects 15% of the global adult population.

Real-World Study Measures Lenire’s Effectiveness in Treating Tinnitus

“Neuromod’s commitment to delivering the highest quality of patient care begins with ensuring our quality management systems are best-in-class,” says Dr Ross O’Neill, Neuromod founder and 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.”

MDR governs the market placement, safety, and performance of medical devices in Europe, replacing Europe’s previous Medical Device Directive (MDD) as the current regulatory framework. MDR introduced significantly more rigorous requirements than MDD to ensure the safety, quality, and reliability of medical devices throughout their lifecycle. Neuromod’s MDR compliance demonstrates the organization’s regulatory and product quality standards. It also ensures Lenire’s continued European availability, provides a robust regulatory framework for future product development of the device, and positions Neuromod to further expand the availability of Lenire in markets that use MDR’s CE mark as a basis for regulatory approvals.

Pictured is Dr Ross O’Neill, CEO and founder of Neuromod Devices.
Pictured is Dr Ross O’Neill, CEO and Founder of Neuromod Devices. Photo – Julien Behal

“Neuromod’s simultaneous approval to MDR and MDSAP assures our healthcare provider partners, and their patients, that Lenire meets the highest safety, quality, and evidence threshold for a tinnitus treatment device,” says Diarmuid Flavin, Neuromod’s chief operating officer. “The transition from MDD to MDR in Europe introduced more rigorous standards for medical device approval. Globally, many non-European markets recognize these standards, which paves the way for us to make Lenire available to more people living with tinnitus worldwide.”

Lenire is a non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in large-scale clinical trials. In 2023, Lenire made regulatory history by becoming the first and only bimodal neuromodulation device to be granted De Novo approval by the US FDA. The De Novo grant was awarded based on the results of TENT-A3, a controlled clinical trial of the novel tinnitus treatment device. 

For more information about Neuromod’s quality and regulatory standards, visit www.neuromod.com/quality-regulatory.