Neuromod, the medical technology 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 follows a comprehensive audit verifying compliance with ISO13485 and specific regulatory requirements in multiple regulatory jurisdictions including Canada (Health Canada) and Australia (TGA).
Following MDSAP certification, Neuromod secured Health Canada and TGA approval to place Lenire on the market in those territories.
Tinnitus, commonly known as ringing in the ears, is a neurological condition that affects 15% of the global adult population1.
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 organisation’s regulatory and product quality standards.
It also ensures Lenire’s continued European availability, provides a robust regulatory framework for future product development and positions Neuromod to further expand the availability of Lenire in markets that use MDR’s CE mark for regulatory approvals.
Lenire is the first bimodal neuromodulation tinnitus treatment device shown to relieve tinnitus in large-scale clinical trials. In 2023, Lenire made 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 for Lenire.
Nature Communications Medicine published the results of 220 real-world tinnitus patients treated with Lenire: 91.5% of patients reported clinically meaningful reductions in tinnitus after treatment with Lenire2, consistent with Lenire’s large-scale clinical trials3,4.
FURTHER INFORMATION:
For more on Neuromod’s quality and regulatory standards, visit www.neuromod.com/quality-regulatory
References: www.neuromod.com/clinical-trials
