The bimodal neuromodulation device is now available through select hearing care clinics across five provinces in Canada.
Neuromod Devices has made its Lenire tinnitus treatment device available in Canada. The device will be exclusively available through hearing care clinics with expertise in tinnitus, with an initial launch including 21 clinics in Ontario, British Columbia, Alberta, Manitoba, and Québec.
Lenire is a bimodal neuromodulation device that combines mild electrical pulses to the tongue via an intra-oral component with auditory stimulation delivered through headphones. The treatment is intended to drive long-term changes in the brain to provide relief from tinnitus. The company plans further expansion of clinic availability in Canada during 2026.
“A high prevalence of tinnitus in Canada is driving demand for clinically proven treatment options. Neuromod is excited to partner with leading tinnitus care clinics to make Lenire available to the millions of people living with constant noise in Canada,” says Dr Ross O’Neill, founder and CEO of Neuromod, in a release.
The Canadian launch follows authorization from Health Canada in late 2025. In 2023, the device was granted De Novo approval by the US Food and Drug Administration based on the results of the TENT-A3 controlled clinical trial, which demonstrated Lenire was clinically superior for tinnitus treatment than sound-therapy alone.
Clinical trial data for the device has been published in Nature – Scientific Reports. The TENT-A2 trial results showed that 95% of compliant patients reported a tinnitus improvement, with 91% reporting that the relief sustained for at least one year after treatment ended. Real-world analyses from independent clinics in the US have also been published. A study from Alaska Hearing & Tinnitus published in Nature Communications Medicine found that 91.5% of 220 patients reported clinically meaningful reductions in tinnitus. Another study from New York Hearing Doctors published in The American Journal of Audiology found that 81.8% of 140 patients reported clinically meaningful relief.
“Hearing Solutions has been treating tinnitus patients for more than 25 years, and we are seeing more patients presenting to our clinicians with tinnitus as their primary concern, reflecting increased awareness and demand for care,” says Ron Abish, founder, president, and CEO of Hearing Solutions, in a release. “We are excited to expand the treatment options for our tinnitus patients with Lenire, a device that has demonstrated strong clinical trial results and real-world effectiveness.”