Key Facts:
● Breakthrough tinnitus treatment device Lenire is now available in Australia following its inclusion in the Australian Register of Therapeutic Goods (ARTG).
● Tinnitus is a major public health issue in Australia, affecting one in four Australian workers, which is significantly higher than the global average.1
● Across two large-scale clinical trials for Lenire, 84% of 517 tinnitus patients experienced sustained relief lasting at least 12 months. 2, 3
● 91.5% of 220 real-world patients experienced clinically meaningful tinnitus relief following Lenire treatment at an independent clinic.⁴
● Treatment is provided under the supervision of qualified hearing healthcare professionals following a suitability assessment.
Neuromod Devices, the global medical technology company, is launching the breakthrough tinnitus treatment device Lenire in Australia. Commonly known as ringing, hissing, or buzzing in the ears, tinnitus is a major public health issue in Australia, affecting one in four workers in 2023, which is well above the global average.
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.
Mini Gupta, Tinnitus and Sound Sensitivity Specialist Audiologist, at the All Ears Hearing and Tinnitus Clinic, Melbourne, believes that evidence-based Lenire represents a leap forward in how tinnitus care is approached.
“Tinnitus is a specialised area, and most doctors were never taught much about it, so when a patient asked, many had little to offer beyond reassurance,” explains Dr Gupta. “Lenire changes that conversation. A clinically trialled tinnitus device, now available in Australia, gives a doctor something to act on: tinnitus is treatable, the treatment has science behind it, and the next step is a referral for a thorough tinnitus assessment. When every doctor has that answer at hand, no patient needs to hear that nothing can be done.”
“Launching Lenire in Australia has been a priority for Neuromod due to the exceptionally high and growing prevalence of the condition in Australia,” says Neuromod Founder and CEO, Dr. Ross O’Neill. “We believe that Lenire will make a significant difference for the Australian tinnitus patients, as well as Australian businesses whose workforce is disproportionately impacted by the condition.”
“Lenire is an additional tool in our tinnitus treatment toolkit,” adds Mini Gupta. “It does not replace the treatments we already use; it adds to them. Until now, taking it up meant travelling overseas. That has changed. After a thorough assessment, patients who are found to be the right candidates can access Lenire here in Australia. And because patients no longer have to wait or travel, treatment can start earlier, which means mental health stays as good as possible while the auditory system settles.”
Lenire is a proven tinnitus treatment that works
The growing body of clinical trial evidence and real-world patient evidence is driving global demand for Lenire. 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) based on the success of its TENT-A3 controlled clinical trial.
Following US FDA approval, the Lenire device was approved by the Medical Device Single Audit Program (MDSAP) and secured authorisation from TGA Australia in late 2025.
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.4
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.6 Leading tinnitus charity Tinnitus UK has rated Lenire the top tinnitus treatment option for safety and effectiveness.
Australian Availability
Lenire is available in clinics across Australia following a suitability assessment. Patients can book a comprehensive tinnitus assessment appointment by visiting www.lenire.com/find-a-clinic.
Neuromod is being supported in its Australian launch by Enterprise Ireland, the Irish Government’s trade and innovation agency, responsible for the development and growth of Irish enterprises in world markets. “We’re delighted to support Neuromod as it brings Lenire to Australia,” says Lydia Rogers, Australia and New Zealand Director, Enterprise Ireland. “This is a groundbreaking technology available now in Australia for the first time. Seeing an Irish company providing a game-changing treatment for the millions of Australians living with tinnitus is exactly the kind of global impact we love to see from Irish innovation.”
References
- Lewkowski et al, The prevalence of tinnitus in the Australian working population, 10.5694/mja2.51354 (2022)
- Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
- 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)
- Mc Mahan, E., and Lim, H. Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment, Commun Med (2025)
- 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)
- Kasper, C et al. Bimodal Neuromodulation for Tinnitus in a Clinical Practice Setting: Clinically Significant Benefit for Patients with Moderate or Worse Symptoms, American Journal of Audiology, https://doi.org/10.1044/2025_AJA-25-00090 (2025)
About us:
About Neuromod Devices
Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland, and the United States of America. Neuromod specialises in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions. The lead application of Neuromod’s technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. www.neuromoddevices.com.
About Lenire®
Lenire® is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in large-scale clinical trials. Lenire® has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe, De Novo Approval Grant by the US FDA, and approval from Therapeutic Goods Australia. www.lenire.com.
