DUBLIN, IRELAND — Neuromod Devices, developer of the Lenire® tinnitus treatment device, announced it has received approval under the Medical Device Single Audit Program (MDSAP) and certification under the European Union Medical Device Regulation (MDR).
MDSAP certification followed a comprehensive audit verifying compliance with ISO13485 and specific regulatory requirements in multiple jurisdictions, including Health Canada and Australia’s Therapeutic Goods Administration (TGA). Following certification, Neuromod secured regulatory approvals from both agencies to market Lenire in those territories.
“Neuromod’s commitment to delivering the highest quality of patient care begins with ensuring our quality management systems are best-in-class. 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.”
–Dr. Ross O’Neill, Neuromod Founder & CEO
Regulatory Significance
Photo credit: Eoin Holland
MDR governs the placement, safety, and performance of medical devices in Europe, replacing the Medical Device Directive (MDD). The updated framework introduced more rigorous requirements to ensure the safety, quality, and reliability of medical devices throughout their lifecycle.
Neuromod’s MDR compliance demonstrates adherence to these standards, ensures Lenire’s continued availability in Europe, and provides a framework for further product development. The certification also positions the company to expand availability in other markets that recognize the CE mark.
“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, Chief Operating Officer at Neuromod.
“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 the first non-invasive bimodal neuromodulation device shown in large-scale clinical trials to reduce tinnitus symptoms. In 2023, it became the first device of its kind to be granted De Novo approval by the U.S. Food and Drug Administration (FDA), based on results from the TENT-A3 controlled clinical trial.
Nature Communications Medicine recently published findings from 220 tinnitus patients treated with Lenire in a real-world clinical setting at Alaska Hearing & Tinnitus Center. According to the study, 91.5% of patients reported clinically meaningful reductions in tinnitus, results consistent with Lenire’s large-scale clinical trials.
For more information about Neuromod’s quality and regulatory standards, visit www.neuromod.com/quality-regulatory.
About Neuromod Devices
Neuromod Devices is a global medical technology company with offices in Ireland and the United States. The company specializes in the development of neuromodulation technologies to address the clinical needs of tinnitus patients. Since 1992, Neuromod has advanced tools and insights to support treatment throughout the patient journey.
About Lenire
Lenire® is a non-invasive bimodal neuromodulation device consisting of Bluetooth® headphones that deliver sequences of audio tones combined with gentle electrical pulses to the tongue via a proprietary device trademarked as Tonguetip®. The system is controlled by a handheld controller, with treatment prescribed and monitored by qualified healthcare professionals such as audiologists or ENT surgeons.
About Tinnitus
Tinnitus, commonly described as “ringing in the ears,” is a neurological condition affecting an estimated 15% of the global adult population, including at least 25 million Americans. It is also the most prevalent service-connected disability compensated by the U.S. Veterans Administration, with more than 3.2 million veterans affected in 2024.
References:
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Global Prevalence and Incidence of Tinnitus. A Systematic Review and Meta-analysis, JAMA (2022).
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McMahan, E., and Lim, H. Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting, Commun Med (2025).
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Brendan Conlon et al. Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study. Sci. Transl. Med. 12, eabb2830 (2020). DOI:10.1126/scitranslmed.abb2830
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Conlon, B., Hamilton, C., Meade, E. et al. Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial. Sci Rep 12, 10845 (2022). https://doi.org/10.1038/s41598-022-13875-x
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https://www.nidcd.nih.gov/health/tinnitus
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US VA Benefits Report Fiscal Year 2024: https://www.benefits.va.gov/REPORTS/abr/
