Tinnitus and Lenire

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