FDA grants tinnitus device De Novo approval in US first

The FDA has granted De Novo approval to Lenire, the first bimodal neuromodulation device of its kind to be approved by the FDA for the treatment of tinnitus.

The De Novo approval is based on the success of Lenire’s third large-scale clinical trial, TENT-A3, supported by Real-World Evidence from 204 patients.

Over the entire trial, 79.4 per cent of the patients experienced a clinically significant improvement, 82.4 per cent were compliant to bimodal treatment, and 88.6 per cent responded that they would recommend Lenire as a tinnitus treatment.

Neuromod Devices Founding CEO, Ross O’Neill, said:

“Lenire’s approval not only means that millions of Americans living with tinnitus can get the treatment they need but further validates over a decade of research and development that resulted in a safe solution that provides relief for tinnitus patients.”

The TENT-A3 primary endpoint analysis showed that patients that were at least moderately bothered by tinnitus achieved a clinically meaningful improvement in tinnitus following the bimodal treatment phase of the trial.

This includes tinnitus-sufferers in the moderate, severe and catastrophic categories as defined by the Tinnitus Handicap Inventory (THI).

The analysis showed that patients in this group were more likely to achieve a clinically meaningful improvement using Lenire’s bimodal sound and tongue stimulation than sound therapy alone.

Tinnitus specialist Dr Leyendecker, owner of The Tinnitus and Hyperacusis Clinic of Minnesota and former  President of Minnesota Academy of Audiology and President Elect of Academy of Doctors of Audiology, said:

“Many tinnitus patients are not availing of currently available options, such as hearing aids and counselling, and success with these options is varied.

“What is especially encouraging about this new bimodal treatment is that it can deliver clinical benefits in as short as six weeks of treatment, which can greatly improve our capacity issues since more patients can be helped in a shorter period of time.”