Neuromod Publishes Results of TENT-A2 Study – The Hearing Review
Neuromod Devices Limited, the Irish medical device company specializing in the treatment of tinnitus, announced the publication of results of the company’s TENT-A2 (Treatment Evaluation of Neuromodulation for Tinnitus – Stage A2) clinical trial in Nature – Scientific Reports in a paper titled “Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial.”
The full paper is available here: TENT-A2 results1.
Tinnitus, commonly referred…….
Neuromod Devices Limited, the Irish medical device company specializing in the treatment of tinnitus, announced the publication of results of the company’s TENT-A2 (Treatment Evaluation of Neuromodulation for Tinnitus – Stage A2) clinical trial in Nature – Scientific Reports in a paper titled “Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial.”
The full paper is available here: TENT-A2 results1.
Tinnitus, commonly referred to as “ringing in the ears” is thought to affect between 10-15% of the global adult population2,3. The TENT-A2 trial, which included 191 participants, is the company’s “second large-scale clinical trial and sought to replicate and further enhance 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 on from the publication of the TENT-A1 results as the cover story in Science – Translational Medicine in 2020 (the full TENT-A1 results paper is available here: TENT-A1 results)4.
The TENT-A2 study investigated if changing treatment stimuli after six weeks of treatment would result in greater improvement in tinnitus symptoms than observed in the TENT-A1 study, during which participants were treated with the same stimuli for the entire 12-week treatment period.
In the TENT-A1 study, treatment compliant participants demonstrated a mean improvement that was more than twice the published clinically important improvement. In the TENT-A2 study, 95% of treatment compliant participants achieved a greater average improvement in symptoms compared to TENT-A11,4,5 and almost three times the published clinically important improvement. 91% of treatment compliant participants achieved an improvement that sustained 12 months after treatment concluded1,5.
TENT-A2 is reportedly “the second large-scale clinical trial validating the safety, with high patient satisfaction and tolerability, of bimodal neuromodulation as a treatment for tinnitus while also 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 available commercially throughout Europe, was developed by Neuromod. It consists of wireless (Bluetooth) headphones 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 trademarked as Tonguetip, according to the company. The device’s settings can be configured to provide treatment with different combinations of audio and electrical stimuli.
The timing, intensity, and delivery of the stimuli are controlled by a handheld controller that each participant is trained to use prior to continuing treatment from home. Before using the treatment for the first time, …….
