Name of treatment

Lenire™

Type of treatment

Bimodal stimulation – sound therapy  with electrical stimulation

Claims for treatment

‘over time the unique signal patterns work to reduce and soothe the perceived tinnitus experience’[1].

How treatment is delivered

Customised sounds delivered via Bluetooth® headphones whilst electrical impulses are delivered to the surface of the tip of the tongue to activate touch nerves (primarily the trigeminal nerve). The device is used daily with follow up visits to a clinician over a three month period.

Potential negative consequences

Sound therapy is generally regarded as safe. The manufacturers claim that the electrical impulses are ‘mild and safe’1,2

Evidence offered:

Papers available

1 (although 4 trials claimed)

Conclusions drawn

Users defined as ‘compliant’ (N=30) demonstrated statistically significant improvements in minimum masking level, tinnitus loudness matching and Tinnitus Handicap Inventory[2]

Quality of evidence[3]

C-

Does the BTA recommend this treatment?

No, not until more high-quality evidence is available.

BTA opinion on this treatment:

There is no independent evidence of the effectiveness of Lenire™. A study has been registered on ClinicalTrials.gov[4] relating to a published study protocol[5] but no results have been published at the time of writing.

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?

 

Generally regarded as safe

Verdict: Efficacy - does this treatment work?

 

No independent evidence that it is effective

Date completed

November 2019

Date for revision

November 2022

Download this information:

Tinnitus and  Lenire™

We welcome feedback on all our information. Please send any corrections or updates for consideration to Nic Wray, Communications Manager on [email protected]

[1] Understanding the technology. Lenire. https://lenire.ie [accessed 12 November 2019]

[2] Hamilton C, D’Arcy S, Pearlmutter BM, Crispino G, Lalor EC, Conlon BJ. An Investigation of Feasibility and Safety of Bi-Modal Stimulation for the Treatment of Tinnitus: An Open-Label Pilot Study. Neuromodulation, 2016; 19: 832-837. DOI: 10.1111/ner.12452

[3] 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

[4] Treatment Evaluation of Neuromodulation for Tinnitus Stage 1 (TENT-A) ClinicalTrials.gov Identifier NCT02669069. https://clinicaltrials.gov [accessed 12 November 2019]

[5] D’Arcy S, Hamilton C, Hughes S, Hall DA, Vanneste S, Langguth B, Conlon BJ. Bi-modal stimulation in the treatment of tinnitus: a study protocol for an exploratory trial to optimise stimulation parameters and patient subtyping. BMJ Open, 2017. Oct 25;7(10):e018465. DOI: 10.1136/bmjopen-2017-018465.

Updated 13 December 2019