Business Wire

NEUROMOD

Share
Neuromod Publishes Results of Large-Scale Tinnitus Clinical Trial in Peer-Reviewed Top-Tier Scientific Journal

Neuromod Devices Limited (“Neuromod”), the Irish medical device company specialising in the treatment of chronic tinnitus, commonly described as ‘ringing in the ears’, has published the results of the Company’s TENT A1 (Treatment Evaluation of Neuromodulation for Tinnitus) clinical trial in this week’s edition of Science Translational Medicine in a paper titled: ‘Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study’.

The clinical trial was conducted between 2016 and 2019 and was designed to track changes in tinnitus symptom severity. The trial investigated the bimodal neuromodulation approach, using Neuromod’s non-invasive stimulation device that delivers sound to the ears and electrical stimulation to the tongue.

The study represents the largest and longest followed-up clinical trial ever conducted in the tinnitus field with 326 enrolled participants, providing evidence regarding the safety, efficacy and patient tolerability of bimodal neuromodulation for the treatment of tinnitus. 86.2% of treatment compliant participants reported an improvement in tinnitus symptom severity when evaluated after 12 weeks of treatment, with many experiencing sustained benefit 12 months post-treatment.

The study was conducted at the Wellcome Trust-HRB Clinical Research Facility, St. James’s Hospital, Dublin, Ireland and the Tinnituszentrum of the University Regensburg, Germany. There were consistent therapeutic outcomes across both clinical sites, with no SAEs Serious Adverse Events (SAEs related to the treatment and a high satisfaction rate across a large cohort of participants. A Medical Research Organization (NAMSA, Minneapolis, Minnesota, USA) guided and assisted the close-out process of Neuromod’s clinical trial.

The tinnitus treatment device, now branded as Lenire®, which was used in the study was developed by Neuromod and consists of wireless (Bluetooth®) headphones that deliver sequences of audio tones layered with wideband noise to both ears, combined with electrical stimulation pulses delivered to 32 electrodes on the tip of the tongue by a proprietary device trademarked as Tonguetip®. The timing, intensity and delivery of the stimuli are controlled by an easy to use handheld controller that each participant is trained to use. Before using the treatment for the first time, the device is configured to the patient’s hearing profile and optimised to the patient’s sensitivity level for tongue stimulation.

For the trial, participants were instructed to use the Lenire® device for 60 minutes daily for 12 weeks. Out of 326 enrolled participants, 83.7% used the device at or above the minimum compliance level of 36 hours over the 12-week treatment period. For the primary endpoints, participants achieved a statistically and clinically significant reduction in tinnitus symptom severity.

When treatment was completed, participants returned their device and were assessed at three follow-up visits up to 12 months. 66.5% of participants who filled out the exit survey (n=272) affirmed they had benefited from using the device and 77.8% (n=270) said they would recommend the treatment for other people with tinnitus.

Participants in the study were screened and selected based on a pre-defined list of inclusion and exclusion criteria to ensure the trial had a wide distribution sample of the tinnitus population. More information on the criteria can be found on https://www.clinicaltrials.gov/ using the identifier NCT02669069 and the full paper can be accessed here: https://www.neuromoddevices.com/tenta1results .

Dr Ross O’Neill, Founding CEO of Neuromod commented: “We are delighted to announce the publication of positive results from our TENT-A1 clinical trial, which has shown significant improvements in tinnitus symptoms in patients using our unique Lenire® device. There is a globally recognised clinical need for evidence-based treatments for tinnitus, such as Lenire®, due to the lack of effective options for this debilitating condition. Neuromod is proud to be at the cutting edge of efforts to research and develop new solutions that can contribute to solving this chronic condition that affects 10-15% of the population worldwide. We are committed to continuing our research in the field and to advance our unique chronic tinnitus treatment technology”.

Hubert Lim, Chief Scientific Officer of Neuromod commented: “I am truly proud of our Company’s ability to perform such a large-scale randomised clinical trial in two countries, enrolling 326 participants to demonstrate the safety and efficacy of a new solution for tinnitus. This study tracked the post-treatment therapeutic effects for 12 months, which is a first for the tinnitus field in evaluating the long-term outcomes of a medical device approach. The outcomes are very exciting and I look forward to continuing our work to develop a bimodal neuromodulation treatment to help as many tinnitus sufferers as possible.”

About Neuromod Devices Limited

Neuromod Devices Limited (“Neuromod”), headquartered in the Digital Hub, Dublin, Ireland, is a medical technology company, specialising in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions. The company was founded in 2010, by Dr. Ross O’Neill. The lead application of Neuromod’s technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder for which no standard of care has yet been established. Neuromod’s tinnitus treatment device Lenire® has been commercialised in Europe and is available in Ireland, Belgium and Germany. Tinnitus affects between 10 and 15% of the global population, and the lives of at least 1 in every 100 people worldwide are severely compromised because of the incessant nature of the illusory sound that is often described as a ringing or buzzing in the ears.

www.NeuromodDevices.com

About Lenire®

Lenire® is the first non-invasive bimodal neuromodulation tinnitus treatment shown to soothe and relieve tinnitus in a large-scale clinical trial. Lenire® has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe. Further details on Lenire® including a list of providers can be found under www.lenire.com .

About Science Translational Medicine

The Science family of journals is published by the American Association for the Advancement of Science (AAAS), the world’s oldest and largest general science organization. The Science magazine has been at the centre of important scientific discovery since its founding in 1880, and continues to publish the very best in research across the sciences, with articles that consistently rank among the most cited in the world. Science Translational Medicine is an essential platform for peer-reviewed, multidisciplinary research driving the latest medical advances to complement the discoveries in the Science magazine.

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Transition Industries Signs Strategic Agreements for the Pacifico Mexinol Project, the Largest Standalone Ultra-Low Carbon Chemical Production Facility in the World30.6.2025 20:30:00 CEST | Press release

Pacifico Mexinol project, a 6,130 MT per day ultra-low carbon methanol production facility worth more than US$3.3b will be located near Topolobampo, Ahome, Sinaloa. Once operational in 2029, Pacifico Mexinol is poised to be the largest standalone ultra-low carbon chemical production facility in the world. Transition Industries LLC, a developer of world-scale, net-zero carbon emissions methanol and green hydrogen projects in North America, held a signing event for an Engineering, Procurement, and Construction (EPC) contract with the consortium of Samsung E&A Co., Ltd. (Samsung E&A), Grupo Samsung E&A Mexico, S.A. de C.V., and Techint Engineering and Construction for the Pacifico Mexinol project located in Ahome, Sinaloa, Mexico, which is contingent upon the fulfillment of customary conditions precedent and obtainment of all required approvals. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630940954/en/ MAIRE group’s techn

Westinghouse and ITER Sign a $180M Contract to Advance Nuclear Fusion30.6.2025 15:45:00 CEST | Press release

The contract includes the assembly of the fusion reactor’s vacuum vessel, a key milestone which gets the project closer to replicating fusion energy on Earth Westinghouse Electric Company and ITER signed a contract for $180 million for the assembly of the vacuum vessel for the fusion reactor. This is a key milestone in the construction of the ITER reactor, leading the way toward the use of fusion as a practical future source of reliable carbon-free energy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630497810/en/ The ITER Tokamak pit with the two vacuum vessel sector modules installed. Westinghouse has participated in the fabrication of the sectors of the vacuum vessel, as part of the Fusion for Energy (F4E) Consortium with its partners Ansaldo Nucleare and Walter Tosto. Westinghouse will be responsible for completing the vacuum vessel which is ITER’s most critical component: a hermetically sealed, double-walled steel

Monetate Acquires SiteSpect to Deliver AI-Native Personalization and Testing at Enterprise Scale30.6.2025 15:00:00 CEST | Press release

Monetate’s Real-Time Personalization Unites with SiteSpect’s Zero-Flicker Testing to Optimize Digital Experiences with Unmatched Speed, Precision, and SecurityNow Global Ecommerce and Digital Experience Leaders Can Access a Best-in-Class, Enterprise-Grade Personalization, Testing, and Optimization Platform Monetate, the leading AI-driven personalization platform, today announced it has acquired SiteSpect, a leader in A/B testing, to drive next-generation digital experience optimization. This acquisition accelerates Monetate’s vision to deliver intelligent, intentional, and individualized experiences at scale, powered by agentic AI and backed by the industry’s most advanced, enterprise-grade infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630514541/en/ The combination of Monetate’s real-time personalization and SiteSpect’s zero-flicker testing will yield an industry-first solution for enterprise-grade person

SS&C Blue Prism Recognized as a Gartner® Magic Quadrant™ RPA Leader for the Seventh Consecutive Year30.6.2025 15:00:00 CEST | Press release

SS&C Technologies Holdings, Inc. (Nasdaq: SSNC) today announced that SS&C Blue Prism has been recognized as a Leader in the 2025 Gartner Magic Quadrant for Robotic Process Automation (RPA). “We’re delighted SS&C Blue Prism has been named a Leader in the Gartner Magic Quadrant for Robotic Process Automation for the seventh year running,” said Bill Stone, CEO and Chairman of SS&C Technologies. “SS&C Blue Prism combines market-leading RPA and orchestration technologies with the latest artificial intelligence so organizations can tackle more complex tasks and dynamic business processes. We’ve scaled to more than 2,700 digital workers and AI agents across our own operations, resulting in over $200 million in annual savings. With SS&C leading the charge on deployment, customers can be confident in rolling out SS&C’s automation solutions securely, effectively, and responsibly.” More than 2,800 companies worldwide leverage SS&C Blue Prism for AI-powered automation, helping organizations delive

Takeda Announces U.S. FDA Approval of GAMMAGARD LIQUID ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content130.6.2025 14:00:00 CEST | Press release

GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with Less Than or Equal to 2 µg/mL IgA in a 10% Solution is Approved for Intravenous or Subcutaneous Use in People Aged Two and Older with Primary Immunodeficiency1U.S. Commercialization of GAMMAGARD LIQUID ERC Projected to Begin in 2026Company Announces Future Manufacturing Discontinuation End Date for Takeda's First-Generation Low-IgA Product, A Freeze-Dried Formulation in Company’s Differentiated Immunoglobulin Portfolio of Ready-to-Use Liquids2 Takeda(TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with less than or equal to 2 µg/mL IgA in a 10% solution, the only ready-to-use liquid immunoglobulin (IG) therapy with low immunoglobulin A (IgA) content, as replacement therapy for people two years of age and older with primary immunodeficiency (PI). As a ready-to-use liquid, GAMMAGARD LIQUID ERC may help ease the administratio

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye