Medical device company Neuromod has welcomed the findings of a study by Germany Hearing Centre (DHZ) at Hannover Medical School, which found that 85% of tinnitus patients experienced a reduction in their symptoms when using its Lenire treatment device.
The study, published in the Brain Stimulation scientific journal, showed that six to 12 weeks of treatment using Lenire, a bimodal neuromodulation device that provides sound and electrical stimulation of the tongue, can achieve safe and clinically meaningful improvements in the severity of tinnitus symptoms.
Neuromod said the data was consistent with the outcomes of its TENT-A1 large-scale clinical trial, which included 326 participants. The results, published in October 2020, showed that 86% of treatment-compliant participants reported improvements in their symptoms after a 12-week period using Lenire.
Dr Ross O’Neill, CEO of Neuromod, commented: “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.
"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.
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Lenire delivers 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 of neuroplasticity in the brain to treat tinnitus.
Neuromod Devices Ltd’s latest accounts filing relates to the year to September 2019, when accumulated losses since incorporation amounted to €18m
Neuromod has raised "significant" venture equity and debt financing, led by life science-focused venture capital fund Foundation Healthcare Partners, to fund ongoing expansion of availability of Lenire in Europe and the organisation's FDA submission process in the US.
Photo: Dr Ross O'Neill, founder and CEO of Neuromod. (Pic: Julien Behal)
