Lenire Tinnitus Device Launches in Canada for Long-Term Relief,
Neuromod Devices, a medical technology firm focused on tinnitus therapies, has introduced its Lenire device to the Canadian market.
Initially, Lenire will be offered through select hearing care clinics specializing in tinnitus across Ontario, British Columbia, Alberta, Manitoba, and Québec. The rollout begins with availability in 21 clinics, with plans to expand further in 2026.
Lenire is the first bimodal neuromodulation system shown in multiple clinical studies to deliver lasting relief from tinnitus. The treatment works by pairing gentle electrical stimulation applied to the tongue via an intra-oral component called Tonguetip with sound-based stimulation, encouraging beneficial changes in brain activity associated with tinnitus.
Tinnitus—often described as ringing, buzzing, or hissing in the ears—is widespread in Canada. According to the Canadian Health Measures Survey, 43% of Canadians have experienced it at some point, and 37% reported symptoms within the past year.
Dr. Ross O’Neill, Founder and CEO of Neuromod, noted that growing demand from Canadians living with tinnitus has driven the device’s launch. He emphasized the company’s commitment to providing clinically validated solutions and collaborating with leading clinics to expand access to care.
The Canadian introduction follows a thorough audit confirming Neuromod’s compliance with ISO13485 standards and regulatory requirements, including approval from Health Canada.
Canada becomes the latest country to offer Lenire in 2026, following successful launches in markets such as the Netherlands, Portugal, and expanded availability in the United States. Lenire is also the first non-invasive bimodal neuromodulation device for tinnitus to demonstrate effectiveness in both controlled clinical trials and real-world patient outcomes.
In 2023, the device received De Novo authorization from the U.S. Food and Drug Administration (FDA), marking a regulatory milestone. This approval was based on results from the TENT-A3 clinical trial, which showed Lenire to be more effective than sound therapy alone. Following FDA clearance, the device also met the requirements of the Medical Device Single Audit Program (MDSAP) and obtained authorization from Health Canada in late 2025.
Neuromod has since been training hearing care professionals across Canada to deliver Lenire treatment. Findings from the TENT-A2 clinical trial, published in Nature – Scientific Reports, showed that 95% of compliant patients experienced improvement, with 91% maintaining benefits for at least a year after treatment.
Ron Abish, Founder and CEO of Hearing Solutions, highlighted the growing number of patients seeking help for tinnitus and welcomed Lenire as an additional, evidence-backed treatment option.
Real-world data further supports the device’s effectiveness. Studies published in Nature Communications Medicine and the American Journal of Audiology reported significant symptom reduction among patients treated at independent clinics, with a large majority experiencing meaningful relief.
Patients have also shared positive outcomes. Toronto resident Jim Gray described Lenire as life-changing, noting that it helped him reduce reliance on sleep medication and manage his tinnitus more effectively.
Reflecting its strong clinical evidence, Lenire has been recognized by the charity Tinnitus UK as a leading treatment option in terms of safety and effectiveness.
In Canada, Lenire is available exclusively through trained hearing care clinics, where patients undergo an assessment to determine suitability before beginning treatment.
Click here to find a clinic providing Lenire in Canada.
Initially, Lenire will be offered through select hearing care clinics specializing in tinnitus across Ontario, British Columbia, Alberta, Manitoba, and Québec. The rollout begins with availability in 21 clinics, with plans to expand further in 2026.
Lenire is the first bimodal neuromodulation system shown in multiple clinical studies to deliver lasting relief from tinnitus. The treatment works by pairing gentle electrical stimulation applied to the tongue via an intra-oral component called Tonguetip with sound-based stimulation, encouraging beneficial changes in brain activity associated with tinnitus.
Tinnitus—often described as ringing, buzzing, or hissing in the ears—is widespread in Canada. According to the Canadian Health Measures Survey, 43% of Canadians have experienced it at some point, and 37% reported symptoms within the past year.
Dr. Ross O’Neill, Founder and CEO of Neuromod, noted that growing demand from Canadians living with tinnitus has driven the device’s launch. He emphasized the company’s commitment to providing clinically validated solutions and collaborating with leading clinics to expand access to care.
The Canadian introduction follows a thorough audit confirming Neuromod’s compliance with ISO13485 standards and regulatory requirements, including approval from Health Canada.
Canada becomes the latest country to offer Lenire in 2026, following successful launches in markets such as the Netherlands, Portugal, and expanded availability in the United States. Lenire is also the first non-invasive bimodal neuromodulation device for tinnitus to demonstrate effectiveness in both controlled clinical trials and real-world patient outcomes.
In 2023, the device received De Novo authorization from the U.S. Food and Drug Administration (FDA), marking a regulatory milestone. This approval was based on results from the TENT-A3 clinical trial, which showed Lenire to be more effective than sound therapy alone. Following FDA clearance, the device also met the requirements of the Medical Device Single Audit Program (MDSAP) and obtained authorization from Health Canada in late 2025.
Neuromod has since been training hearing care professionals across Canada to deliver Lenire treatment. Findings from the TENT-A2 clinical trial, published in Nature – Scientific Reports, showed that 95% of compliant patients experienced improvement, with 91% maintaining benefits for at least a year after treatment.
Ron Abish, Founder and CEO of Hearing Solutions, highlighted the growing number of patients seeking help for tinnitus and welcomed Lenire as an additional, evidence-backed treatment option.
Real-world data further supports the device’s effectiveness. Studies published in Nature Communications Medicine and the American Journal of Audiology reported significant symptom reduction among patients treated at independent clinics, with a large majority experiencing meaningful relief.
Patients have also shared positive outcomes. Toronto resident Jim Gray described Lenire as life-changing, noting that it helped him reduce reliance on sleep medication and manage his tinnitus more effectively.
Reflecting its strong clinical evidence, Lenire has been recognized by the charity Tinnitus UK as a leading treatment option in terms of safety and effectiveness.
In Canada, Lenire is available exclusively through trained hearing care clinics, where patients undergo an assessment to determine suitability before beginning treatment.
Click here to find a clinic providing Lenire in Canada.
Companies