Neuromod has announced the publication of the results of a clinical trial which has shown bimodal neuromodulation combining sound and electrical stimulation of the tongue can significantly reduce tinnitus symptoms.
The results of the TENT A1 (Treatment Evaluation of Neuromodulation for Tinnitus) trial, which were published in peer-reviewed journal Science Translational Medicine also showed that therapeutic effects can be sustained for up to 12 months post-treatment.
The clinical trial was conducted between 2016 and 2019 and was designed to track changes in tinnitus symptom severity. The trial investigated the bimodal neuromodulation approach, using Neuromod’s non-invasive stimulation device that delivers sound to the ears and electrical stimulation to the tongue.
The study represents the largest and longest followed-up clinical ever conducted in the tinnitus field with 326 enrolled participants, providing evidence regarding the safety, efficacy and patient tolerability of bimodal neuromodulation for the treatment of tinnitus.
A total of 86.2% of treatment compliant participants reported an improvement in tinnitus symptom severity when evaluated after 12 weeks of treatment, with many experiencing sustained benefit 12 months post-treatment.
The study was conducted at the Wellcome Trust-HRB Clinical Research Facility (St. James’s Hospital, Dublin, Ireland) and the Tinnituszentrum of the University Regensburg, Regensburg, Germany.
The tinnitus treatment device, now branded as Lenire, which was used in the study was developed by Neuromod and consists of wireless bluetooth headphones that deliver a sequences of audio tones layered with wideband noise to both ears, combined with electrical stimulation pulses delivered to 32 electrodes on the tip of the tongue by a proprietary device trademarked as Tonguetip.
The timing, intensity and delivery of the stimuli are controlled by a handheld controller that each participant is trained to use. Before using the treatment for the first time, the device is configured to the patient’s hearing profile and optimised to the patient’s sensitivity level for tongue stimulation.
For the trial, participants were instructed to use the Lenire device for 60 minutes daily for 12 weeks. Out of 326 enrolled participants, 83.7% used the device at or above the minimum compliance level of 36 hours over the 12-week treatment period. For the primary endpoints, participants achieved a statistically and clinically significant reduction in tinnitus symptom severity.
When treatment was completed, participants returned their device and were assessed at three follow-up visits up to 12 months. A total of 66.5% of participants who filled out the exit survey (n=272) affirmed they had benefited from using the device and 77.8% (n=270) said they would recommend the treatment for other people with tinnitus.
Ross O’Neill, founding CEO of Neuromod, said: “We are delighted to announce the publication of positive results from our TENT-A1 clinical trial, which has shown significant improvements in tinnitus symptoms in patients using our unique Lenire device.
“Neuromod is proud to be at the cutting edge of efforts to research and develop new solutions that can contribute to solving this chronic condition that affects 10–15% of the population worldwide. We are committed to continuing our research in the field and to advance our unique chronic tinnitus treatment technology.”