Information What can I do? Treatments Tinnitus and Lenire Tinnitus and Lenire™ Name of treatment Lenire™ Type of treatment Bimodal stimulation – sound therapy with electrical stimulation Claims for treatment Lenire® is retraining the brain to reduce its attention and sensitivity to the tinnitus sound that was previously active in the brain. Lenire® presents different sounds and stimulus patterns on the tongue, which activates different cells and regions in the auditory pathway of the brain, as well as other emotional and cognitive regions in the brain.[1] How treatment is delivered Lenire® combines sound stimulation via headphones to the ear with electrical stimulation to the tongue via a device which rests on the tip of the patient’s tongue.[2] The device is used for 60 minutes daily for 12 weeks. Potential negative consequences Some people have reported exacerbation of tinnitus[3]; cost Evidence offered: Papers available Three Conclusions drawn 81% of participants experienced an improvement in tinnitus symptoms after 12 weeks of treatment and 77% at 12 months post-treatment, irrespective of the study arm they were on (based on THI and TFI scores). 16% of participants reported that their tinnitus got worse. At the end of treatment, 66.5% of participants said that they had benefitted from using the device. The study also found that there wasn’t as large of an improvement in tinnitus symptoms during the second 6-weeks of stimulation, as there was during the first 6-weeks. This suggests that the brain may become less sensitive in response to repetitive stimuli over time.[4] Quality of evidence[5] B Does the BTA recommend this treatment? Further clinical trials are required before bimodal neuromodulation could be established as a clinically recommended treatment for tinnitus. BTA opinion on this treatment: This paper is the first high quality paper evaluating the effectiveness of a bimodal neuromodulation device (Lenire®) to reduce the perception of tinnitus. However, it is sponsored by the device manufacturers so is not fully independent. Would the BTA support further studies into this treatment? Yes, provided the study is of high quality and fully independent Verdict: Safety - is this treatment harmful? Limited potential for harm Verdict: Efficacy - does this treatment work? No independent evidence that it is effective Date completed December 2020 Date for revision December 2023 Download this information: tinnitus and lenire DEC 2020 [1] https://www.lenire.com/what-is-lenire [accessed 23 October 2020] [2] https://www.lenire.com/the-science-of-lenire [accessed 23 October 2020] [3] Conlon B, Langguth B, Hamilton C, Hughes S, Meade E, O’Connor C, Schecklmann M, Hall DA, Vanneste S, Leong SL, Subramanian T, D’Arcy S, Lim HH. (2020) ‘Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study.’ Science Translational Medicine. 12:564. DOI: 10.1126/scitranslmed.abb2830 [4] Conlon B, Langguth B, Hamilton C, Hughes S, Meade E, O’Connor C, Schecklmann M, Hall DA, Vanneste S, Leong SL, Subramanian T, D’Arcy S, Lim HH. (2020) ‘Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study.’ Science Translational Medicine. 12:564. DOI: 10.1126/scitranslmed.abb2830 [5] A = Systematic review/meta analysis. B = Randomised control studies. C = Cohort studies. D = Case control studies. E = case studies/reports. +/- to be used to indicate quality within bands We welcome feedback on all our information. Please send any corrections or updates for consideration to Nic Wray, Communications Manager on [email protected] Updated 3 December 2020