Lenire: The FDA Approved Tinnitus Device and How it Can Help You

Dec 09, 2025
Photo: Eoin Holland

Lenire is a treatment device proven to reduce the severity of tinnitus.

Lenire is the first device of its kind to receive a grant of approval from the FDA to treat tinnitus. This follows a large-scale clinical trial designed to meet the FDA’s requirements during which 83% of patients recommended Lenire for the treatment of tinnitus. The largescale trial’s results were consistent with real-world evidence from 204 patients*.

Photo: Eoin Holland

 

The device plays sounds from headphones and provides gentle pulses to the tongue via a Tonguetip. The sounds and pulses work together to retrain your brain. You pay less attention to your tinnitus reducing its impact on your day-to-day life.

Headphones: Bluetooth headphones, which are included with Lenire, deliver customized sounds to activate the auditory nerve to the brain.

The Tonguetip: Specifically designed to treat tinnitus, sits comfortably in the closed mouth. Tiny electrodes on the Tonguetip deliver mild and safe pulses to the surface of the tip of the tongue.

Controller: A lightweight handheld device that controls the timing and intensity of the treatment. You can start, pause and resume the treatment session, adjust the volume of the sound, and adjust the level of the tongue stimulation.

 

 

 

The settings are customized by your healthcare professional to suit your tinnitus after an assessment to make sure you’re suitable. Autumn Oak Hearing & Balance is a trained provider of treatment of tinnitus with Lenire. Get in touch today to book an assessment for Lenire. 

Learn more about tinnitus here!