- Neuromod will make Lenire available to the estimated 8 million adults living with tinnitus across Canada and Australia in 2026.1
- Neuromod will create 25 full time high skilled roles across engineering, operations, software development, sales and marketing to support this latest expansion.
- Lenire will be available through 17 hearing clinic locations in Canada with rollout beginning from March 1, 2026, with Australian market entry planned for Q4 2026.
- Neuromod will continue to grow Lenire’s European footprint with expansion into the Netherlands and Portugal.
DUBLIN, Feb. 26, 2026 /PRNewswire/ — Neuromod Devices, an Irish medical technology business specialising in tinnitus treatment, has announced plans to commercialise the Lenire tinnitus treatment device in Canada and Australia in 2026.
Neuromod’s planned Lenire expansion will create 25 highly skilled full-time roles in research & development, engineering, software development, sales, marketing, and business administration across Ireland, Canada and Australia.
Lenire will be available through 17 hearing healthcare clinic locations in Canada with rollout beginning from March 1, 2026. Australian expansion is planned for Q4 2026.
The announcement 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), and Australia (TGA).
Neuromod will also continue to grow Lenire’s European footprint by making the medical device available in the Netherlands and Portugal in March, 2026.
“The peer-reviewed positive outcomes of patients treated with Lenire by our American clinical partners has catalysed a demand surge for Lenire in Australia and Canada in the patient and healthcare provider communities,” said Dr. Ross O’Neill, Neuromod Devices Founder and CEO. “Neuromod is proud to make Lenire available in Canada, Australia and more European countries, and to work with our clinical partners to deliver best-in-class tinnitus care for the millions of people living with the condition in those territories.”
Tinnitus – A Chronically Underserved Condition
Tinnitus, which is commonly known as ringing in the ears, is a complex neurological condition that affects 15% of the global adult population.1 It is estimated that 8 million people are living with tinnitus across Canada and Australia.1
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. Lenire’s bimodal neuromodulation combines tongue and auditory stimulation to drive long-term changes in the brain that have been proven to relieve tinnitus severity.
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).
Lenire is Proven in Clinical Trials and with Real Patients
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.2
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.3
Nature Communications Medicine recently published the results of 220 tinnitus patients treated with Lenire in a real-world clinical setting at Alaska Hearing & Tinnitus Center. 91.5% of patients reported clinically meaningful reductions in tinnitus after treatment with Lenire.4
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 through a qualified hearing healthcare professional. Tinnitus patients who wish to have a suitability assessment can find a Lenire Clinic by visiting lenire.com/find-a-clinic.
About Neuromod Devices
Neuromod Devices is a global medical technology company with offices in Ireland and the USA. Neuromod specialises in the design and development of neuromodulation technologies to address the clinical needs of tinnitus patients.
Neuromod has completed extensive clinical trials to confirm the safety and effectiveness of its non-invasive bimodal neuromodulation tinnitus treatment device, Lenire, to treat this common but underserved disorder.
References
- R. Biswas et al., Tinnitus prevalence in Europe: a multi-country cross-sectional population study, The Lancet Regional Health (2021)
- Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, nature.com/articles/s41598-022-13875-x (2022)
- Boedts, M., Beuchner, A., Khoo, S.G. et al Combining sound with tongue stimulation for the treatment of tinnitus. A multi-site single-arm controlled pivotal trial. Nature Comms. (2024)
- Mc Mahan, E., and Lim, H. Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment, Commun Med (2025)
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