This paper describes the results from a double blinded randomised control trial examining the efficacy of bimodal neuromodulation for the treatment of bothersome subjective tinnitus. The Lenire device pairs sound therapy with the electrical stimulation of touch sensitive neurons within the tongue. The purpose of this method is to supress and reduce the activity level of overactive nerve cell groups in the hearing centre of the brain that are linked to the emergence of tinnitus awareness. This is achieved by increasing the activity of other neural populations within central auditory system so that, through neural plastic processes, patients become less consciously aware of their tinnitus perception. The device provides sound and tongue stimulation to patients with a very specific timing pattern designed to augment the therapeutic effect.
In order to explore the safety and effectiveness of this method 326 adult patients with long-term tinnitus were tested in 3 separate groups at 2 different trial sites. Each group received a variation of sound therapy and experienced a different temporal arrangement with respect to how the sound stimulation was paired with the transcutaneous electrical stimulation of the tongue.
Results showed that 84 % of patients completed the 12-week trial with 81% of subjects recording a significant change in tinnitus severity questionnaires. Approximately 77% indicated that this effect lasted beyond the treatment phase of 12 weeks. Qualitatively 66% of trial subjects reported that they felt that they had benefited from using the device. There were no significant outcome differences for the three groups.