- Lenire® will be available through new clinics in London, Durham, Kenilworth, and Aberystwyth to increase the tinnitus treatment device’s accessibility for 9 million people in the UK living with tinnitus.1
- FDA Approved Lenire® has been proven to be more effective than sound-only therapy for people with moderate and above tinnitus in a landmark clinical trial.2
- Lenire® is proven to provide long term relief for at least 12-months after treatment concluded in 91% of patients in its second clinic trial.3.5
- An analysis of 220 real world Lenire patients revealed that 91.5% had a clinically meaningful reduction in tinnitus after 12-weeks of treatment with Lenire.3,5
London, England, February 11, 2025: Neuromod Devices, the medical device company that specialises in tinnitus treatment, has announced they are partnering with 4 UK clinics to expand the availability of Lenire®, the clinically proven tinnitus treatment device.
Tinnitus, which is commonly known as “ringing in the ears,” is a complex neurological condition that causes the constant perception of noise when there is no external source. Tinnitus affects an estimated 9 million people in the UK.
Lenire® is a bimodal neuromodulation device which has been proven to provide long lasting relief from tinnitus across multiple clinical trials. Lenire treats tinnitus through a combination of auditory and tongue stimulation that retrains the brain to significantly reduce tinnitus focus.
This latest expansion doubles the number of clinics providing Lenire in the UK, adding new partnerships with Harley Street Hearing in London, Alto Hearing and Tinnitus in Kenilworth, Durham Hearing Specialists in Durham, and Aberystwyth Hearing in Aberystwyth.
Matthew Allsop, Partner at Harley Street Hearing & Musicians' Hearing Services, spoke about the impact that “cutting-edge” Lenire can have on the lives of tinnitus patients at the clinic
"We are delighted to introduce Lenire to our range of tinnitus therapies, offering patients an innovative and evidence-based solution for tinnitus management,” said Matthew Allsop, Harley Street Hearing & Musicians' Hearing Services Partner.
“At Harley Street Hearing, our commitment is to provide advanced, patient-focused care, and Lenire is a valuable addition to our mission of improving lives through cutting edge audiology.”
Lenire’s demand is owed to the prevalence of tinnitus, and the device being proven safe and effective across three large-scale clinical trials that featured over 600 patients.
Lenire’s most recent clinical trial, TENT-A3, was a controlled clinical trial that compared Lenire to sound-only, which was the trial’s control. TENT-A3 was conducted as part of Lenire’s successful De Novo submission to the US FDA. Lenire was shown to be clinically superior to sound-only for the majority of patients with bothersome tinnitus. The majority of participants with bothersome tinnitus who underwent six weeks of sound-only stimulation also reported that a further six weeks of Lenire provided additional benefit for their tinnitus.
Results from Lenire’s second large-scale clinical trial, TENT-A2, were published in the prestigious scientific journal, Nature – Scientific Reports. TENT-A2 showed that modifying stimuli halfway through treatment resulted in a greater clinically significant improvement in tinnitus severity.2 95% of compliant patients reported a tinnitus improvement, 91% of whom reported a sustained improvement for a year after the treatment ended.
Analysis of 220 real world Lenire patients further validated Lenire’s effectiveness as a tinnitus treatment device. The pre-published paper showed that 91.5% of patients at Alaska Hearing and Tinnitus had a clinically significant reduction in tinnitus after 12-weeks of treatment with Lenire.3,5
“Tinnitus is one of the largest unmet needs in healthcare. Partnerships with leading hearing and tinnitus care clinics in the UK expands the accessibility of Lenire, and ensures that the specific needs of tinnitus patients are met,” said Dr. Ross O’Neill, Neuromod Devices Founder and CEO.
Lenire is now available through hearing and tinnitus care clinics in the UK. Tinnitus patients can find a nearby clinic, and book an appointment by visiting www.lenire.com/find-a-clinic.
About Neuromod Devices
Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland, Germany and 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. For more information visit 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 and has received a De Novo Approval Grant by the US FDA. Further details about Lenire® including a list of providers can be found at www.lenire.com.
References
- R. Biswas et al., Tinnitus prevalence in Europe: a multi-country cross-sectional population study, The Lancet Regional Health (2021), https://doi.org/10.1016/j.lanepe.2021.100250
- Boedts M, B. A., Khoo G, et al. Combining sound with tongue stimulation for the treatment of tinnitus: a controlled pivotal trial. Nature communications (2024)
- Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://www.nature.com/articles/s41598-022-13875-x (2022)
- McMahan, E.E. and Lim, H.H., 2024. Effectiveness of bimodal neuromodulation for tinnitus treatment in a real-world clinical setting in the United States: A retrospective chart review. medRxiv, pp.2024-08; doi: https://doi.org/10.1101/2024.08.22.24312175 [preprint]
- As measured by Tinnitus Handicap Inventory (THI).
- Neuromod Devices Ltd., Lenire (CR-201) Clinician’s Manual, (2023)
