On Mar. 6, 2023, Neuromod Devices announced that the U.S. Food and Drug Administration (FDA) had 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.

Tinnitus, which is commonly known as ‘ringing in the ears’, is a complex neurological condition that causes a perception of sound when there is no external source. It is estimated that at least 25 million Americans are currently suffering from tinnitus. Tinnitus is a silent burden on the USA’s national healthcare system. It is estimated to cost an estimated $660 per patient per year for visits to clinics alone.

The affliction is also the most prevalent and fastest-growing service-connected disability compensated for by The US Veterans Administration (VA). More than 2.7 million veterans were compensated in 2022 and 12% year-on-year growth. It is estimated that the VA paid out more than $4.9 billion through its Veterans Compensation benefits program for tinnitus alone in 2022, with further undisclosed expenditure on treatments, such as hearing aids, sound therapy and counseling, which deliver varying levels of success.

The FDA’s 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% of the patients experienced a clinically significant improvement, 82.4% were compliant to bimodal treatment, and 88.6% responded that they would recommend Lenire as a tinnitus treatment.

The TENT-A3 primary endpoint analysis showed that patients that were at least moderately bothered by tinnitus, which includes patients in the moderate, severe and catastrophic categories as defined by the Tinnitus Handicap Inventory (THI), achieved a clinically meaningful improvement in tinnitus following the bimodal treatment phase of the trial.

The analysis showed that this patient group were more likely to achieve a clinically meaningful improvement using Lenire’s bimodal sound and tongue stimulation than sound therapy alone. This clinical trial also demonstrated that Lenire is inherently safe with zero serious adverse events.

Patients with tinnitus are prescribed Lenire by an appropriately qualified healthcare professional, such as an Audiologist or ENT Surgeon. After an assessment for suitability and can complete treatment from home in between follow-up appointments with their clinician.