Neuromod Devices Ltd.

Stimulating Possibilities

Neuromod Devices Ltd is a global medical technology company with offices in Ireland, Germany and the United States of America. Neuromod Devices’ mission is to research and develop technologies that address the clinical needs of those with underserved conditions.

Neuromod Device’s mission is achieved through commitment to evidence-based solutions, cross-industry collaboration and community engagement.

Lenire Tinnitus Treatment Technology

Tinnitus treatment device, Lenire, is the lead application of Neuromod Devices’ innovative technology development.

Lenire^® combines mild pulses to the tongue, through an intraoral Tonguetip^®, with auditory stimulation through headphones to drive relief from tinnitus^1,2. This is known as bimodal neuromodulation. Lenire is customised to each patient’s hearing profile by a qualified healthcare professional and is then used at home for a prescribed period.

In 2023, Lenire became the first device of its kind approved for the treatment of tinnitus in the USA following a De Novo grant from the US FDA. Lenire also has CE-mark certification and is available under the supervision of a qualified healthcare professional throughout Europe and the USA.

Neuromod’s groundbreaking bimodal neuromodulation device, Lenire’s real-world results for the relief of tinnitus have been proven consistent with large-scale clinical trials.^1,2,3

The results of Lenire^®’s first clinical trial, TENT-A1 (Treatment Evaluation of Neuromodulation for Tinnitus), were published as the cover story for Science Translational Medicine.

TENT-A1 involved 326 enrolled participants, making it one of the largest and longest followed-up tinnitus device clinical trials ever conducted. 86.2% of treatment compliant participants reported an improvement in tinnitus severity when evaluated after 12 weeks of treatment. 80.1% had sustained improvement 12 months post-treatment.

Results from Lenire’s second large-scale clinical trial, TENT-A2, were published in the prestigious scientific journal, Nature – Scientific Reports. TENT-A2 showed that modifying stimuli halfway through treatment resulted in a greater clinically significant improvement in tinnitus severity. 95% of compliant participants reported a tinnitus improvement, 91% of whom reported a sustained improvement for a year after the treatment ended.

Lenire^®’s US FDA De Novo Grant was awarded based on the success of Lenire’s third large-scale clinical trial, TENT-A3, which was accompanied by the results of 204 real-world patients. During this controlled clinical trial, 79.4% of the all patients had a clinically significant reduction in tinnitus severity and 88.6% responded that they would recommend Lenire^®4. Importantly, Lenire^® was proven to be more effective than sound-only therapy for 70.5% of patients with moderate or worse tinnitus.

Ótologie Tinnitus Care Clinic

In 2019, Neuromod established Ótologie Tinnitus Care Clinic, a global centre for tinnitus care excellence. Ótologie offers online and in-clinic tinnitus care in Europe.

Thousands of tinnitus patients have received treatment by a dedicated team of audiologists who specialise in tinnitus and the best clinical practices for the condition.

Neuromod Devices has trained more than 100 clinicians around the world to treat tinnitus patients with Lenire and other treatments, leaning on expertise acquired through Òtologie.

Neuromod Devices Expertise

Neuromod Devices assembled a Science Advisory Board of opinion leading scientists in the field of tinnitus research to provide guidance on the company’s research. This includes exploratory and confirmatory trials, such as TENT-A1,2,3, at internationally recognised clinical sites to build the evidence base for our interventions.

Lenire’s Scientific Advisory Board includes Prof. Berthold Langguth, Consultant Neuropsychiatrist at the Department of Psychiatry and Psychosomatic Medicine at University of Regensburg Hospital (UHREG), Germany; Prof. Sven Vanneste, Professor of Neurosciences at TCD in Ireland; and Prof. Deborah Hall is a Professor of Hearing Sciences in the Faculty of Medicine & Health Sciences at the University of Nottingham, UK.

Neuromod Devices is led and was founded by CEO and biomedical engineer, Dr Ross O’Neill. Neuromod’s Chief Scientific Officer is Prof. Hubert Lim, University of Minnesota; and Chief Medical Officer is ENT surgeon Mr Brendan Conlon, St. James’ Hospital, Dublin and Trinity College Dublin (TCD).

The wider Neuromod team includes ear, nose and throat (ENT) surgeons, neuroscientists, audiologists, clinicians, engineers, regulatory experts, product designers and others who are instrumental to the company’s work of making an evidence-based bimodal neuromodulation intervention available to people with tinnitus.

References

Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://www.nature.com/articles/s41598-022-13875-x (2022)
Buechner A, Lesinski-Schiedat A, Becker P, Lenarz T, Real-world clinical experience with bimodal neuromodulation for the treatment of tinnitus - A case series, Brain Stimulation (2022), doi: https://doi.org/10.1016/j.brs.2022.01.022.
TENT-A3 clinical trial data in preparation for publication. https://clinicaltrials.gov/ct2/show/NCT05227365

Journal
Resources

News

Nature Communications Medicine Publishes Positive, Real World Data for Tinnitus Patients Treated with Unique, FDA Approved Stimulation Device
April 28, 2025 Nature Communications Medicine has published the first peer reviewed, real-world analysis of U.S. patients treated with Lenire, the only FDA approved tinnitus treatment device of its kind.

Lenire Supports Veterans by Sponsoring Hearoes Tour
April 7, 2025 Lenire proudly sponsors the 10th Annual LexCare Hearing Foundation Hearoes Tour. Lenire is a treatment option for 3.2m veterans living with tinnitus.

Neuromod Closes €10 Million Financing to Accelerate Commercialization
March 11, 2025 Neuromod Devices Ltd. (Neuromod), an Irish medical device company specialising in tinnitus, has successfully closed a €10 million equity financing to expand the availability of its tinnitus treatment device, Lenire.

UK Clinics Providing Lenire Tinnitus Treatment Device Double in Latest Expansion
February 11, 2025 Neuromod Devices, the medical device company that specialises in tinnitus treatment, has announced they are partnering with 4 UK clinics to expand the availability of Lenire®, the clinically proven tinnitus treatment device.

Real World Data Supports Lenire Tinnitus Treatment Effectiveness Shown in Large-Scale Clinical Trials
September 4, 2024 The first real-world analysis of tinnitus patients treated with Lenire in the United States has been submitted to a journal for peer-review and is now available on an online pre-print server for health services, medRxiv.

Neuromod Partners with 14 New US Tinnitus Clinics to Expand Availability of FDA Approved Lenire
June 27, 2024 The number of practice partners providing Lenire across the USA has increased to more than 80 in Lenire’s second US expansion of 2024.Lenire will be expanding the number of clinics in California, Texas, Illinois, and Florida to address signific

FDA-Approved Lenire Tinnitus Device Now a Treatment Option for 2.9 Million US Veterans Through Veterans Affairs
June 17, 2024 Neuromod USA Inc. has been awarded a Federal Supply Schedule 65 II Medical Equipment and Supply Contract from the US Government

Breakthrough Tinnitus Treatment Device Lenire Expands Clinics in Spain
April 5, 2024 The breakthrough tinnitus treatment device, Lenire, is now available in four clinics in Spain – Barcelona, Malaga, Seville, and Granada. In Lenire’s second clinical trial, TENT-A2, 91% of patients reported long-term relief from tinnitus that sustained for at least 12 months. Lenire has been proven to be more effective than sound-alone for patients with moderate or worse tinnitus in a controlled large-scale clinical trial. Additionally, 88% of over 500 clinical trial patients would recommend Lenire to treat tinnitus. Lenire is the only tinnitus treatment device of its kind to be awarded a CE-Mark in Europe and FDA Approval in the United States of America.

FDA Approved Lenire Expands Number of US Clinics
February 29, 2024 Neuromod Devices, the medical technology company that developed tinnitus treatment device, Lenire, has partnered with an additional 24 new US clinics to address the significant demand for the FDA-approved tinnitus treatment device.

Lenire Now Available in Monaco Through Otoneuro
February 22, 2024 Neuromod Devices, the medical technology business behind tinnitus treatment device, Lenire, has partnered with state-of-the-art hearing and balance centre, Otoneuro, to make Lenire available in Monaco.

Neuromod Expands Lenire’s US Availability to More Than 50 Providers
October 10, 2023 Neuromod Devices has completed the training and onboarding of additional healthcare professionals in the USA to treat tinnitus patients with Lenire, its bimodal neuromodulation device.

Neuromod Devices Closes €30 Million Financing to Expand Availability of Tinnitus Treatment Device Lenire®
April 13, 2023 Neuromod Devices Ltd, an Irish medical device company specialising in neuromodulation, has successfully closed a €30 million financing to further commercialise its tinnitus treatment device, Lenire.

FDA Grants Lenire® Tinnitus Treatment Device De Novo Approval
March 7, 2023 Neuromod Devices Ltd. announced today that the US Food and Drug Administration (FDA) has granted De Novo approval to Lenire, the first bimodal neuromodulation device of its kind to be approved by the FDA for the treatment of tinnitus.

Neuromod Publishes Results of Second Large Scale Clinical Trial for Tinnitus in Top-Tier Scientific Journal, Shows Greater Improvement of Symptoms
June 30, 2022 Neuromod Devices Limited has published the results of the company’s TENT-A2 (Treatment Evaluation of Neuromodulation for Tinnitus – Stage A2) clinical trial in the highly regarded scientific journal, Nature.

Lenire®, the Treatment Device Shown to Reduce Tinnitus Symptoms in 86.2% Of Patients, Is Now Available in Norway
May 20, 2022 Lenire®, the treatment device shown to reduce tinnitus symptoms in 86.2% of patients, is now available in Norway.

Neuromod Establishes Global Commercial Leadership Team
April 7, 2022 Neuromod Devices Ltd. has announced the formation of a global commercial leadership team to direct the commercialization of its Lenire tinnitus treatment device through key partnerships.

Resources

Hearing Aid Users Received Additional Benefit in Their Tinnitus Journey with Lenire® Bimodal Neuromodulation Treatment

Tinnitus, commonly known as ringing in the ears, is the phantom auditory sensation that affects 10–15% of the adult population.

January 28, 2025

Clinical Experience with Lenire - Case Report of a Patient with Catastrophic Symptom Severity

This real world case study details how Lenire helped a catastrophic tinnitus patient lower their THI score from 94 to 27.

December 20, 2023

Clinical Experience with Lenire®- Case Report of a Patient whose Vestibular Symptoms Improved

This real world case study details how a patient with tinnitus and vestibular condition lowered his tinnitus from 55 THI to 16 THI. As an unexpected side benefit, this patient also gained improved balance.

December 20, 2023

Psychotherapy Case Study of Patient attending Tinnitus Therapy (Otologie – Dublin)

A combination of cognitive behaviour therapy and Lenire helped a real-world patient lower their THI score from 66 to 14.

December 20, 2023

Contact Information

Neuromod Devices Ltd.

Stimulating Possibilities

Lenire Tinnitus Treatment Technology

Ótologie Tinnitus Care Clinic

Neuromod Devices Expertise

References

News

Resources