Neuromod publishes results of second large-scale tinnitus clinical trial in leading scientific journal and shows greater improvement in symptoms
– Second large-scale trial shows greater reduction in tinnitus symptom severity using bimodal neuromodulation device, Lenire®
– 91% of treatment-compliant participants saw improvement in tinnitus symptoms that continued 12 months after treatment
– 87.8% said they would recommend treatment to others with tinnitus
DUBLIN, June 30, 2022 /PRNewswire/ — Neuromod Devices Limited, the Irish medical device company specializing in the treatment of tinnitus, has published the results of the company’s TENT-A2 (Treatment Evaluation of Neuromodulation for Tinnitus – Stage A2) clinical trial in the highly regarded scientific journal, Nature – Scientific Reports in an article titled: “Different Bimodal Neuromodulation Parameters Reduce Tinnitus Symptoms in a Large Randomized Trial.”
The full article is available here: TENT-A2 results.
Tinnitus, commonly known as ‘ringing in the ears’, is thought to affect between 10-15% of the world’s adult population[2,3]. The TENT-A2 trial, which included 191 participants, is the company’s second large-scale clinical trial and aimed to replicate and further improve the results demonstrated in the company’s TENT-A1 trial, a study that evaluated the safety and efficacy of Lenire®, the company’s non-invasive bimodal neuromodulation device in 326 participants.
The publication of the TENT-A2 results in Nature – Scientific Reports follows the publication of the TENT-A1 results on the cover of Science – Translational Medicine in 2020 (the full TENT-A1 results are available here: TENT-A1 results). This second major publication continues Neuromod’s strategy to establish clinical credibility in bimodal neuromodulation by publishing large-scale clinical trials in leading peer-reviewed journals.
The TENT-A2 study investigated whether changing processing stimuli after six weeks of treatment would lead to greater improvement in tinnitus symptoms than was seen in the TENT-A1 study, in which participants were treated with the same stimuli throughout the 12-week treatment period.
In the TENT-A1 study, treatment-compliant participants demonstrated mean improvement that was more than double the published clinically important improvement. In the TENT-A2 study, 95% of treatment-compliant participants achieved greater mean improvement in symptoms compared to TENT-A1[1,4,5] and nearly three times the published clinically important improvement. 91% of treatment-compliant participants achieved improvement that was sustained 12 months after treatment ended[1,5].
TENT-A2 is the second large-scale clinical trial validating the safety, with high patient satisfaction and tolerance, of bimodal neuromodulation as a treatment for tinnitus while demonstrating greater efficacy in reducing tinnitus symptoms through optimized treatment regimens compared to the first large-scale trial.
Bimodal neuromodulation is the stimulation of nerves with two paired stimuli for therapeutic purposes. The tinnitus treatment device that was used in the study, known as Lenire and commercially available Europe, was developed by Neuromod. It consists of wireless headphones (Bluetooth®) that deliver sequences of audio tones to both ears, combined with electrical stimulation pulses delivered to the surface of the tongue via 32 electrodes on a proprietary device under the Tonguetip® brand. Device parameters can be configured to provide treatment with different combinations of audio and electrical stimuli.
Timing, intensity, and delivery of stimuli are controlled by an easy-to-use handheld controller that each participant is trained to use before continuing treatment at home. Before using the treatment for the first time, the device is configured according to the patient’s hearing profile and optimized according to the patient’s sensitivity level for tongue stimulation.
As with TENT-A1, participants in the TENT-A2 trial were asked to use Lenire for 60 minutes every day for 12 weeks. However, after the first six weeks of treatment, the timing and delivery of audio and language stimuli were altered for participants in the TENT-A2 trial for the remaining six weeks of treatment. In TENT-A1, the stimulation parameter remained the same for the full 12 weeks of treatment. This change in treatment regimen resulted in a greater mean reduction in tinnitus symptom severity achieved by treatment-compliant participants[1,4,5].
The study was conducted at the Wellcome Trust-HRB Clinical Research Facility, St. James Hospital, Dublin, Ireland no treatment-related serious adverse events (SAEs) were reported and high treatment compliance. Of 191 enrolled participants, 83.8% used the device at or above the minimum compliance level during the 12-week treatment period.
After treatment was completed, participants returned their devices and were assessed at three follow-up appointments for up to 12 months. 70.3% of the 172 participants who completed the exit survey said they had benefited from using the treatment and 87.8% said they would recommend others with tinnitus to try the treatment ..
Participants were screened and screened based on a predefined list of inclusion and exclusion criteria that enrolled a representative sample of the wider tinnitus population. Further information on the criteria can be found using identifier NCT03530306 at https://www.clinicaltrials.gov.
Speaking to the news, Dr. Ross O’NeillFounding CEO of Neuromod, said, “We are delighted to announce the publication of positive results from the TENT-A2 clinical trial which show greater improvement in tinnitus symptoms with Lenire treatment. Tinnitus remains one of the greatest unmet clinical needs globally and I am proud that Neuromod is at the forefront of developing bimodal neuromodulation technology to treat chronic tinnitus. The publication of two large-scale clinical trials in internationally renowned peer-reviewed journals with positive results for a tinnitus treatment device is a historic milestone, and we’re committed to continuing our research in this area in order to ‘further improve patient outcomes.”
Hubert LimScientific Director of Neuromod, said, “I’m proud of our company’s ability to build on our previous research by enrolling 191 participants in another large-scale clinical trial that showed even greater improvements in tinnitus symptoms. compared to our previous large-scale study. when adjusting the stimulation pattern over time. The successful completion of two large-scale trials is a major milestone in our ongoing work to develop a treatment to help as many people living with tinnitus and to further demonstrate bimodal neuromodulation as a safe and effective intervention for people living with the disease. »
About Neuromod Devices Ltd
Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. Neuromod specializes in the design and development of neuromodulation technologies to meet the clinical needs of underserved patient populations living with chronic and debilitating diseases. The primary application of Neuromod’s technology is in the area of tinnitus, where Neuromod has conducted extensive clinical trials to confirm the effectiveness of its non-invasive neuromodulation platform in this common disorder. Neuromod’s tinnitus device, Lenire, is currently available everywhere Europe. For more information, visit www.neuromoddevices.com.
Lenire is the first non-invasive bimodal neuromodulation tinnitus therapy device shown to soothe and relieve tinnitus in a large-scale clinical trial4. Lenire is CE certified for the treatment of tinnitus under the supervision of a suitably qualified healthcare professional in Europe. Further details of Lenire, including a list of suppliers, are available at www.lenire.com.
About Nature – Scientific Reports
Scientific Reports is an open access journal publishing original research in all areas of the natural sciences, psychology, medicine and engineering and a member of the Nature family of research journals. Scientific Reports is the 6th most cited journal in the world, with more than 540,000 citations in 20206and receives wide attention in policy documents and the media.
Connect with Neuromod Devices Ltd:
Neuromod Devices website: neuromoddevices.com
Lenire website: www.lenire.com
1. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Scientific representativehttps://doi.org/10.1038/s41598-022-13875-x (2022).
2. Baguely et al., Tinnitus, The Lancet (2013), https://www.sciencedirect.com/science/article/pii/S0140673613601427.
3. McCormack, A., Edmondson-Jones, M., Somerset, S. & Hall, D. A systematic review of reporting the prevalence and severity of tinnitus. Listen Res. 337, 70–79. https://doi.org/10.1016/j.heares.2016.05.009 (2016).
4. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020).
5. As measured by Tinnitus Handicap Inventory (THI).
6. 2020 Journal Citation Reports® Science Edition (Clarivate Analytics, 2021).
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