Lenire®

About Lenire

Lenire “works to retrain neurons in the brain to reduce its attention and sensitivity to the tinnitus sound.” [1]

What is Lenire?

Lenire® is a medical device that combines sound therapy with mild electrical stimulation of the tongue. It is typically used for 60 minutes per day over a minimum of 12 weeks.

“Lenire® delivers mild electrical pulses to the tongue combined with sound played through headphones”. [2]

How does it work?

Customised sound therapy is delivered through headphones, while mild electrical pulses are applied via a mouthpiece. These have the combined effect of encouraging changes in how the brain processes tinnitus.

Side effects & risks

• Around one third of participants in clinical trials reported a temporary worsening of tinnitus symptoms. In most cases, this resolved by the end of the study.
• Not everyone benefits from treatment
• Durability beyond 12 months after finishing treatment is not yet well established for all groups.

What does the research say?

In clinical trials:

• 95% of treatment-compliant participants reported an improvement in Tinnitus Handicap Inventory (THI) scores after 12 weeks. [3,4]
• 84% reported improvement in Tinnitus Functional Index (TFI) scores. [4]
• Large trials (TENT‑A1, TENT‑A2) reported clinically meaningful average reductions in Tinnitus Handicap Inventory (THI) and Tinnitus Functional Index (TFI) during treatment. Benefits persisted for some participants at follow‑up.[4]
• A one‑arm controlled pivotal study (TENT‑A3) compared 6‑weeks sound‑only then 6‑weeks bimodal in the same participants. In those with moderate or worse tinnitus at baseline, bimodal showed higher responder rates than sound‑only. No device‑related serious adverse events were reported. [6,7]
• Real‑world clinic cohorts (including a UK/Europe network and US clinics) report improvements broadly consistent with trials [1,2,5,7]

Access & regulation

UK & Europe: CE‑marked medical device available through private clinics.[5]
USA: De Novo classification granted by the FDA creating a new Class II category for combined acoustic and electrical stimulation devices for tinnitus (brand availability through trained providers). [7]

Lenire is not routinely available on the NHS. Clinics set their own fees, which may include assessment, device hire/purchase, and follow‑up.

Additional comments

Neuromod Devices Limited (the makers of Lenire®) are Corporate Members of Tinnitus UK, and have previously sponsored our Annual Conference and Tinnitus Week activity. This treatment sheet should is not an advert for Lenire, and has not been sponsored by Neuromod Devices Limited.