Neuromod Devices Ltd.

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

1. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020) 

2. 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)

3. 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.

4. TENT-A3 clinical trial data in preparation for publication. https://clinicaltrials.gov/ct2/show/NCT05227365