Neuromod welcomes real-world evidence demonstrating the safety & efficacy of the Lenire tinnitus device
Irish medical device company, Neuromod Devices Ltd. (Neuromod), has welcomed the findings of an independent study performed at the German Hearing Center (DHZ) at Hannover Medical School, which found that 85% of tinnitus patients experienced a reduction in their tinnitus symptoms (based on the Tinnitus Handicap Inventory(i) score across 20 patients) when using the Lenire treatment device.
This study showed that six to 12 weeks of treatment using Lenire, a bimodal neuromodulation device developed by Neuromod that provides sound and electrical stimulation of the tongue, can safely achieve clinically meaningful improvements in tinnitus symptom severity in a real-world clinical setting.
The study was led by Drs. Thomas Lenarz, Anke Lesinski-Schiedat, and Andreas Buechner from the Department of Otolaryngology at the Hannover Medical School, Germany.
These results were (link: https://www.brainstimjrnl.com/article/S1935-861X(2200028-6/fulltext text: recently published in the highly ranked scientific journal, Brain Stimulation)(ii).
The real-world data are consistent with the outcomes of Neuromod’s large-scale clinical trial (TENT-A1), which included 326 participants. The TENT-A1 trial, the results of which were published in October 2020(iii), showed that 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms after a 12-week period using Lenire.
The Hannover study involved shorter durations of treatment (6-12 weeks) and observed a mean improvement (reduction) in THI score of 10.4 points, which exceeds the clinically meaningful difference of 7 points. This real-world data from the Hannover study is in line with the TENT-A1 study, which observed similar improvements after 6 weeks of treatment and achieved a total of 14.6 points improvement after a full 12 weeks of treatment. Furthermore, there were no reported treatment-related adverse events.
Commenting on the publication of this new analysis, Dr Ross O’Neill, CEO and Founder of Neuromod said: “Results from real-world studies can turn out to be different from those of clinical trials, for a variety of reasons, so it is really encouraging to see that the study performed by Professor Lenarz’s team showed similar levels of efficacy and safety for the Lenire device as in our own large-scale TENT-A1 clinical study, which was published as the cover story in Science Translational Medicine just over a year ago. The Hannover study involved shorter-term use than our studies but we saw similar levels of improvement after 6 weeks of use in the TENT-A1 study. Furthermore, there were no reported treatment-related adverse events with Lenire, confirming the device’s safety in a real-world setting. We are committed to contributing to the body of evidence of using bimodal neuromodulation to treat tinnitus and we were encouraged to see Lenire perform well on studies conducted by eminent Otolaryngology clinicians and researchers, such as Professor Thomas Lenarz and his team in Hannover.”
Lenire works by delivering mild electrical pulses to the tongue, through an intra-oral component called the ‘Tonguetip’, combined with sound played through headphones to drive long-term changes or neuroplasticity in the brain to treat tinnitus.
The TENT-A1 clinical trial, which involved 326 participants across Ireland and Germany, demonstrated Lenire’s efficacy in improving participant’s tinnitus symptoms. 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms after a 12-week treatment period(iv). When followed up 12 months post treatment, 80.1% of treatment-compliant participants had sustained improvements in their tinnitus symptoms.
The TENT-A1 study represents one of the largest and longest followed-up clinical trials ever conducted in the tinnitus field and was the cover story for the scientific journal Science Translational Medicine in October 2020.
Neuromod specialises in non-invasive neuromodulation technologies and has designed and developed Lenire, which has been used to treat tinnitus patients since 2019.
To date Neuromod has raised significant venture equity and debt financing to fund ongoing expansion of the availability of Lenire in Europe and the organisation’s FDA submission process in the US. This funding has been led by Fountain Healthcare Partners; an international life science focussed venture capital fund.
(i) Tinnitus Handicap Inventory is a clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. Measured on a scale of 100, the higher the score, the greater the impact of tinnitus. Reducing a person’s THI score should correspond to improved quality of life by reducing how their tinnitus is affecting them.
(ii) 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.
(iii) Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
(iv) As measured by Tinnitus Handicap Inventory score