Neuromod Devices has welcomed the findings of an independent study performed at the German Hearing Center at Hannover Medical School (Hannover, Germany), which found that 85% of tinnitus patients experienced a reduction in their tinnitus symptoms—based on the Tinnitus Handicap Inventory (THI) score—across 20 patients when using the Lenire 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, as per a press release from the company.
The study was led by Thomas Lenarz, Anke Lesinski-Schiedat and Andreas Buechner from the Department of Otolaryngology at Hannover Medical School in Hannover, Germany. Its results were recently published in Brain Stimulation.
The real-world data are consistent with the outcomes of Neuromod’s large-scale clinical trial, TENT-A1, which included 326 participants across Ireland and Germany, the release continues. The TENT-A1 trial—the results of which were published in Science Translational Medicine in October 2020—showed that 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms after a 12-week period using Lenire. When followed up 12 months post-treatment, 80.1% of treatment-compliant participants had sustained improvements in their symptoms as well.
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 seven points. These real-world data are in line with the TENT-A1 study, which observed similar improvements after six 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, according to Neuromod.
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 six 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.