Neuromod secures global regulatory approvals for Lenire tinnitus device
Dublin-based medical device company Neuromod Devices has secured critical regulatory approvals that will expand global access to its Lenire tinnitus treatment system. The company announced simultaneous approvals for Medical Device Single Audit Program (MDSAP) certification and EU Medical Device Regulation (MDR) compliance.
Dr Ross O’Neill, Neuromod founder and CEO
Regulatory milestone opens new markets
The MDSAP certification follows comprehensive auditing that verified compliance with international standard ISO13485 and specific regulatory requirements across multiple jurisdictions. This achievement directly enabled regulatory approval from both Australia’s Therapeutic Goods Administration (TGA) and Health Canada for market placement.
“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 and CEO. “MDSAP and MDR certification allows Neuromod to continue expanding Lenire’s availability in Europe whilst positioning the company to commercialise Lenire in new geographies such as Australia, Canada and beyond.”
Clinical evidence supports expanded access
Lenire represents the first non-invasive bimodal neuromodulation device demonstrated to provide tinnitus relief in large-scale clinical trials. The system combines wireless headphones delivering audio sequences with electrical stimulation pulses applied to the tongue surface via a proprietary 32-electrode device called Tonguetip.
Recent real-world clinical data published in Nature Communications Medicine examined 220 tinnitus patients treated at Alaska Hearing & Tinnitus Center. Results showed 91.5% of patients reported clinically meaningful tinnitus reductions following Lenire treatment, consistent with previous large-scale clinical trial outcomes.
FDA breakthrough paves international pathway
In 2023, Lenire achieved regulatory history by becoming the first bimodal neuromodulation device granted FDA De Novo approval for tinnitus treatment. This precedent-setting approval was based on the controlled TENT-A3 clinical trial results.
“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,” said Diarmuid Flavin, Neuromod’s chief operating officer.
- For more information, visit: https://neuromod.com/
