Neuromod Devices has earned Medical Device Single Audit Program (MDSAP) approval and EU Medical Device Regulation (MDR) certification for its Lenire tinnitus treatment device.

Neuromod gained MDSAP certification after undergoing 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). After MDSAP certification, Neuromod secured both Health Canada and TGA approval to place Lenire on the market in those territories.

Commonly known as ringing in the ears, tinnitus is a complex neurological condition that affects 15% of the global adult population.¹

“Neuromod’s commitment to delivering the highest quality of patient care begins with ensuring our quality management systems are best-in-class,” Neuromod Founder/CEO Dr. Ross O’Neill said. “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 medical device safety, quality, and reliability throughout their lifecycle. Neuromod’s MDR compliance demonstrates the organization’s regulatory and product quality standards, according to the company. 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.

“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,” Neuromod Chief Operating Officer Diarmuid Flavin stated. “The transition from MDD to MDR in Europe introduced more rigorous standards for medical device approval. Globally, many non-European markets recognise 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 tinnitus treatment device shown to soothe and relieve tinnitus in large-scale clinical trials. In 2023, Lenire became the first and only bimodal neuromodulation device to be granted FDA De Novo approval. The De Novo grant was awarded based on the results of TENT-A3, a controlled clinical trial of the novel tinnitus treatment device. 

Nature Communications Medicine recently published the results of 220 tinnitus patients treated with Lenire in a real-world clinical setting at Alaska Hearing & Tinnitus Center. Data show 91.5% of patients reported clinically meaningful reductions in tinnitus after treatment with Lenire.² These results are consistent with Lenire’s large-scale clinical trials.^3,4 

Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in large-scale clinical trials. Bimodal neuromodulation is nerve stimulation with two paired stimuli for therapeutic purposes. The tinnitus treatment device used in the study (Lenire), consists of wireless (Bluetooth) headphones that deliver sequences of audio tones to both ears, combined with electrical stimulation pulses delivered to the surface of the tongue through 32 electrodes on a proprietary device trademarked as Tonguetip. The device’s settings can be configured to provide treatment with different combinations of audio and electrical stimuli.

The stimuli’s timing, intensity, and delivery are controlled by an easy-to-use handheld controller that each participant is trained to use before undergoing treatment from home. Patients with tinnitus are prescribed Lenire by an appropriately qualified healthcare professional, such as an audiologist or ENT surgeon, after an assessment for suitability and can complete treatment from home in between follow-up appointments with their clinician.

Tinnitus is a complex neurological condition that causes a perception of sound when there is no external source. An estimated 25 million Americans are currently living with tinnitus.⁵ The condition is also the most prevalent service-connected disability compensated for by The U.S. Veterans Administration (VA), with more than 3.2 million veterans compensated in 2024.⁶

Neuromod Devices is a global medical technology company with offices in Ireland and the United States that designs and develops neuromodulation technologies to address tinnitus patients’ clinical needs. The company has completed extensive clinical trials to confirm Lenire’s safety and effectiveness.

References
1 Global Prevalence and Incidence of Tinnitus. A Systematic Review and Meta-analysis, JAMA (2022).
2 Mc Mahan, E., and Lim, H. Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting, Commun Med (2025).
3 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
4 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 
5 https://www.nidcd.nih.gov/health/tinnitus
6 US VA Benefits Report Fiscal Year 2024: https://www.benefits.va.gov/REPORTS/abr/