Neurostimulation Device for Tinnitus Treatment – De Novo FDA Clearance

Photo credit: Neuromod 

It’s a breakthrough that may prove to be as uplifting as music to the ears of tinnitus sufferers worldwide.

This month saw the United States’ Food and Drug Administration (FDA) grant De Novo regulatory clearance to tinnitus treatment device, the Lenire system by Neuromod.

Thought to impact up to 20 percent of the population, tinnitus a common neurological condition which typically presents as a ringing or buzzing noise in one or both ears, in the absence of external noise (Mayo Foundation for Medical Education and Research, 2023).

Comprised of three components – a device placed inside the mouth which drives mild energy pulses to the tip of the tongue; a handheld controller; and Bluetooth headphones sending customised sounds to the brain – the Lenire system works to reduce the symptoms associated with tinnitus. It is used under the supervision of a trained clinician.

The greenlight from the FDA followed a series of large-scale clinical trials, following which Neuromod reported nearly 80 percent of participants experienced “clinically significant improvement” in their tinnitus after using the Lenire technology.

“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,” Dr Ross O’Neill, founding CEO of Neuromod Devices said in a press statement.

The non-invasive Lenire device is the first of its kind to receive FDA approval to treat tinnitus in the United States, and has already had CE clearance in Europe. Neuromod is set to begin rolling out the system across the United States from April.

Read the full announcement or visit the Neuromod Devices website for further information.