Noninvasive device for treating tinnitus receives FDA de novo approval

The FDA has granted de novo approval to Neuromod Devices’ Lenire, a noninvasive device for the treatment of tinnitus and the first of its kind to receive approval in the United States, according to a company press release.

The approval is based on the bimodal neuromodulation device’s success in the TENT-A3 clinical trial, which included 112 patients with tinnitus. Participants underwent 6 weeks of treatment with Lenire — a device that combines acoustic and electrical intraoral stimulation — and 6 weeks of sound therapy only.

According to the release, 79.4% of patients experienced clinically significant improvement, and 88.6% said they would recommend Lenire. Additionally, 82.4% of patients complied with treatment. The findings were consistent with real-world evidence from 204 patients.

“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,” Ross O’Neill, PhD, MBA, founder and CEO of Neuromod Devices, said in the release. “Lenire is the first bimodal neuromodulation device to go through the rigors of the FDA’s de novo process. For patients that are at least moderately impacted by their tinnitus, Lenire has now been shown to be more effective than sound therapy, which is one of the current clinical standards of treatment.”

According to the release, the company will begin training audiologists and ear, nose and throat surgeons on the use of Lenire, which will be available in the U.S. in April 2023.

The FDA explains on its website that de novo approval “provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.”

Reference:

• FDA. De novo classification request. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request#:~:text=The%20De%20Novo%20request%20provides,no%20legally%20marketed%20predicate%20device. Updated Oct. 4, 2022. Accessed March 10, 2023.