86.2% of compliant TENT-A1 participants reported improvement in their THI score after 12 weeks of treatment
80.1% of compliant TENT-A1 participants reported improvement in their THI score that continued for 12 months after treatment ended
Neuromod has invested in clinical trials involving more than 500 participants
To understand how Lenire works, first we look at the science of neuromodulation. Neuromodulation in its modern form is a therapy that has been used successfully for a wide variety of health and brain conditions, from physical pain and epilepsy to movement disorders and depression. Most recently, it has emerged as a potential treatment for the symptoms of tinnitus. Simply put, neuromodulation aims to alternate neural activity through a targeted delivery of a stimulus, such as stimulation of a nerve. It works by targeting a specific nerve or brain region with a stimulus, such as low levels of electrical energy, in order to alter or adjust the activity within the body or brain to improve a health condition.
Lenire®, a new potential treatment for tinnitus, takes neuromodulation one step further by stimulating two nerves at the same time. This is known as ‘bimodal neuromodulation’.
Various research and clinical studies have shown that the combined stimulation of auditory (via the ear) and somatosensory nerves (via the tongue, for example), which is achieved using the non-invasive Lenire® treatment, is more effective when it comes to inducing the positive neuroplasticity important to ease the tinnitus symptoms than stimulating one input at a time. This serves to counter the unhelpful neuroplasticity that gives rise to tinnitus in the first place.
This particular bimodal treatment - which is the first commercially available treatment of its kind - combines sound stimulation to the ear with gentle electrical stimulation to the tongue. The signals are coordinated through the Lenire® control device, which plays soothing sounds through the recommended headphones while sending electrical pulse signals through the tonguetip™ device. The Tonguetip® rests on the tip of the patient’s tongue. This diverse activity in the brain not only interferes with the ongoing activity caused by tinnitus, but also makes the brain attend to the novel or changing stimuli that are being continuously presented to the individual, leading to an individual being less aware or bothered by their tinnitus.
To date, clinical trials involving more than 500 participants using Lenire® have taken place. Our published TENT-A1 study showed that 86.2% of treatment compliant participants reported an improvement in their THI score after 12 weeks of treatment, with 80.1% reporting improvement that continued for 12 months after treatment.
TENT-A1 Research Paper: Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study (2020)
TENT-A1 Supplementary Materials: Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study (2020)
TENT-A1 Protocol Paper (2017)
TENT-A2 Protocol Paper (2019)
Safety and Feasibility Study (2016)
Tinnitus Alleviation Via Sensory Stimulation: Safety and Feasibility Study, 60 participants
Treatment Evaluation of Neuromodulation for Tinnitus Stage 1 (TENT-A)
Double-blinded randomized trial, 326 participants.
Treatment Evaluation of Neuromodulation for Tinnitus Stage A2 (TENT-A2)
Double-blinded randomized trial, 191 participants.