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

October 2020

Date for revision

October 2023

Download this information:

tinnitus and lenire oct 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 23 October 2020