Neuromod Devices Ltd is a medical technology company which specialises in the design and development of neuromodulation technologies to address the clinical needs of those with chronic and debilitating conditions. The first application of Neuromod’s technology has been the development of a treatment device for chronic tinnitus, which remains a significant clinical need. The bimodal neuromodulation device for tinnitus treatment has undergone large-scale clinical trials with more than 500 participants to confirm its efficacy. The results of the first of these trials, TENT-A1 (Treatment Evaluation of Neuromodulation for Tinnitus), were published as the cover story in Science Translational Medicine’s October 2020 magazine.
TENT-A1 is one of the largest and longest followed-up clinical trial ever conducted for a tinnitus device 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 (as measured by Tinnitus Handicap Inventory) when evaluated after 12 weeks of treatment, with 80.1% of treatment compliant participants reporting sustained improvement 12 months post-treatment.
Neuromod has convened a Science Advisory Board of opinion leading scientists in the field of tinnitus research to provide guidance on the company’s research, including exploratory and confirmatory trials, such as TENT-A1, at internationally recognised clinical sites to build the evidence base for our interventions. This 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.
In 2019, Neuromod established Neuromod Medical, a clinical center of excellence for tinnitus care in Europe. Since then, thousands of people with tinnitus have used the service provided by a dedicated team of audiologists who specialise in tinnitus and the best clinical practices for the condition.
The company is led and was founded by CEO and biomedical engineer, Dr Ross O’Neill. Its 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.
Due to this commitment to research, regulatory, and clinical practice, Neuromod’s bimodal neuromodulation device for tinnitus has CE-mark approval for use in the treatment of tinnitus patients in Europe. Neuromod is seeking approval from the Food and Drug Administration to make the device available in the USA.