What Is Lenire and What Does It Mean for Tinnitus Treatment?

Woman wearing headphones; lenire for tinnitus treatment concept

Lenire is a noninvasive tinnitus treatment device developed by Neuromod Devices, an Irish medical technology company.

In March 2023, the FDA granted the Lenire neuromodulation device de novo approval. This approval is granted when a new medical device provides a reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.

The device reduces the symptoms of tinnitus by combining mild electrical pulses to the tongue with sound stimulation.

Lenire consists of a set of bluetooth headphones that deliver tailor-made sounds to the wearer, along with a handheld controller that allows users to adjust the sound levels and settings, and a tonguetip wand.

What is Bi-modal Neuromodulation?

Bi-modal neuromodulation refers to the use of two different forms of neuromodulation, in this case, the use of both auditory and tongue stimulation, to treat tinnitus. The Lenire device uses sounds delivered through headphones as well as electrical stimulation of the tongue to achieve the desired neuromodulatory effect.

The idea behind using bi-modal neuromodulation is that by stimulating multiple sensory pathways, the brain is more likely to respond to the treatment and reduce the perception of tinnitus.

The specific sounds and electrical stimulation used by Lenire are designed to target the neural pathways involved in the perception of tinnitus, and the treatment is personalized for each individual based on their specific tinnitus symptoms and hearing profile.

Lenire has been shown to be effective in reducing the symptoms of tinnitus in clinical trials.

According to the Lenire website, "91% of trial participants who used Lenire as directed reported a reduction in their symptoms that was sustained for 12 months after treatment ended. This is significant for people searching for long-term relief from tinnitus."

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