Lenire Tinnitus Treatment Device Now Available in Canada

TORONTO — Neuromod Devices, the medical technology company that specializes in tinnitus treatment technology, has made the Lenire^® tinnitus treatment device available in Canada.

Nearly half of all Canadian adults have experienced tinnitus in their lifetime and a new at-home tinnitus treatment device offers chronic sufferers hope.

• Lenire tinnitus treatment device now available in Canada through 21 clinics across Alberta, British Colombia, Manitoba, Ontario, and Québec.
• 43% of Canadians (11.2m) report experiencing tinnitus in their lifetime with 37% of Canadians (9.2m) report experiencing tinnitus in the past year according to data from a Canadian Health Measures Survey (CHMS).¹
• 84% of 517 tinnitus patients across two large-scale clinical trials reported relief from tinnitus that sustained for at least 12-months.^2,3
• 91.5% of tinnitus patients reported significant relief from tinnitus in a peer-reviewed analysis of patients treated with Lenire at an independent clinic.⁴

Lenire will be exclusively available through hearing care clinics with expertise in tinnitus in Ontario, British Columbia, Alberta, Manitoba, and Québec. Lenire will be available in 21 clinics as part of the device's initial Canadian launch, with further expansion planned in 2026.

Lenire is the first bimodal neuromodulation device that has been proven to provide long-term relief from tinnitus across multiple clinical trials.^2,3 The device combines mild pulses to the surface of the tongue via an intra-oral component called the 'Tonguetip®', with auditory stimulation to drive changes to the brain and deliver long-term relief from tinnitus.

Tinnitus is commonly known as ringing, hissing, or buzzing in the ears. 43% of Canadians report experiencing tinnitus in their lifetime with 37% reporting experiencing tinnitus in the past year according to a Canadian Health Measures Survey.¹

Lenire’s availability in Canada follows a comprehensive audit that verified Neuromod’s compliance with the international standard ISO13485 and regulatory requirements in multiple regulatory jurisdictions including Canada (Health Canada).

Lenire is Proven to Provide Long-Term Tinnitus Relief in Clinical Trials

Canada is the latest country to make Lenire available in 2026, following successful launches in The Netherlands, Portugal, and further expansion in the USA.

Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device that has been proven effective in clinical trials and in real world patient analyses.

In 2023, Lenire made regulatory history by becoming the first and only bimodal neuromodulation device to be granted De Novo approval by the United States of America Food and Drug Administration (US FDA).

De Novo Approval from the FDA was granted based on the success of Lenire’s TENT-A3 controlled clinical trial. TENT-A3 demonstrated that Lenire was clinically superior for the treatment of tinnitus than sound-therapy, which was the trial’s control.⁵ Following US FDA approval, the Lenire device was approved for the Medical Device Single Audit Program (MDSAP) and secured authorization from Health Canada in late 2025.

Since then, Neuromod has been training hearing care professionals with tinnitus expertise throughout Canada to provide treatment with Lenire.

Nature-Scientific Reports published results from Lenire’s second large-scale clinical trial, TENT-A2. TENT-A2 showed 95% of compliant patients reported tinnitus improvement. 91% reported long-term relief that sustained for at least a year after treatment ended.¹

Lenire Proven Effective with Tinnitus Patients Treated at Independent Clinics

Results from Lenire’s real world patient analyses are consistent with the bimodal neuromodulation device’s clinical trial patient outcomes.

Nature Communications Medicine peer-reviewed and published the results of real world patients with bothersome tinnitus treated with Lenire at Alaska Hearing & Tinnitus. 91.5% of 220 patients reported clinically meaningful reductions in tinnitus after treatment with Lenire.²

The American Journal of Audiology published results of 140 real-world patients with bothersome tinnitus treated at New York Hearing Doctors. 81.8% of 140 patients reported clinically meaningful relief from tinnitus after treatment with Lenire.

“Due to my tinnitus, I had to take medication to get to sleep, which I hated to do and I was worried that it was going to get even worse.” said Toronto-based tinnitus patient, Jim Gray. "Lenire demonstrated to me that you can solve problems like tinnitus, it has been a miracle that has changed my life, "

Acknowledging the large evidence-based, Lenire has been rated as the top tinnitus treatment option for safety and effectiveness by leading tinnitus charity, Tinnitus UK.

Lenire is available in Canada exclusively through hearing care clinics comprehensively trained to administer tinnitus care with Lenire following a suitability assessment. Patients can find a clinic providing Lenire in Canada by visiting the Lenire Find-a-Clinic website.

SOURCE: Neuromod