- MDSAP certification is an essential milestone towards commercialisation of the Lenire tinnitus treatment device in Australia and Canada.
- Following MDSAP certification, Neuromod Devices have secured regulatory approval for Lenire from both Australia's Therapeutic Goods Administration (TGA) and Health Canada.
- MDR certification supports the continued availability of Lenire in the European market and enables further availability of Lenire beyond Europe.
- Lenire made regulatory history in 2023 by becoming the first and only FDA Approved bimodal neuromodulation tinnitus treatment device.
DUBLIN, Sept. 23, 2025 /PRNewswire/ -- 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 population1.
"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 & 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 organisation'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.
"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. "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 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.
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. 91.5% of patients reported clinically meaningful reductions in tinnitus after treatment with Lenire2. These results are consistent with Lenire's large-scale clinical trials3,4.
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 USA. Neuromod specializes in the design and development of neuromodulation technologies to address the clinical needs of tinnitus patients.
Neuromod has completed extensive clinical trials to confirm the safety and effectiveness of its non-invasive bimodal neuromodulation tinnitus treatment device, Lenire, to treat this common but underserved disorder.
For more information about Neuromod visit www.neuromod.com.
About Lenire
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 the stimulation of nerves with two paired stimuli for therapeutic purposes. The tinnitus treatment device that was used in the study, known as Lenire, was developed by Neuromod Devices. It 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 via 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 timing, intensity and delivery of the stimuli are controlled by an easy-to-use handheld controller that each participant is trained to use prior to continuing 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.
About Tinnitus
Tinnitus, which is commonly known as 'ringing in the ears', is a complex neurological condition that causes a perception of sound when there is no external source. It is estimated that at least 25 million Americans are currently living with tinnitus5. Tinnitus is also the most prevalent service-connected disability compensated for by The United States Veterans Administration (VA), with more than 3.2 million veterans compensated in 20246.
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 Rep12, 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/
Photo - https://mma.prnewswire.com/media/2779046/Professor_Ross_O_Neil.jpg
View original content:https://www.prnewswire.co.uk/news-releases/neuromod-advance-multiple-regulatory-approvals-to-expedite-global-availability-of-lenire-302563534.html
