Lenire (tinnitus reduction device)

2023: Market Entry

In early March 2023, Neuromod Devices announced the entry into the market of the Lenire neuromodulation device for the treatment of tinnitus.

The Lenire became the first bimodal neuromodulation device of its kind to treat tinnitus, according to a press release. The instrument delivers faint electrical pulses to the tongue, combined with sound played through headphones. This promotes long-term changes or neuroplasticity in the briana to treat tinnitus. An audiologist or ENT surgeon prescribes and installs a device to draw up an individual treatment plan.

Neuromod Devices CEO Ros O'Neill

The product entered the market after the third large-scale TENT-A3 trial from March to October 2022 at three independent sites. Real data showed that out of 204 patients, 79.4% showed clinically significant improvement. Results included 82.4% adherence to bimodal treatment. According to Neuromod Devices, 88.6% of patients said they would recommend Lenire as a tinnitus treatment. Testing of the device demonstrated safety: there were no serious adverse events. The controlled study TENT-A3 compared the effects of six weeks of bimodal neuromodulation and six weeks of sound therapy alone.

For patients who experience at least moderate exposure to tinnitus, Lenire has proven more effective than sound therapy, according to Neuromod Devices CEO Ross O'Neill. The approval FDA means millions of Americans suffering from tinnitus will be able to get the treatment they need and confirms more than a decade of research and development.

According to the developers, this approval sets the bar higher on the regulatory category for medical devices in the United States. Neuromod Devices has been training healthcare professionals since January 2023. The company plans to treat the first patients with tinnitus in the United States in April 2023.^[1]

2020: Lenire announcement - devices to reduce tinnitus

In mid-October 2020, a group of researchers from different countries showed that the Lenire neurostimulation system, created by the Irish company Neuromod Devices, can significantly reduce ringing in the ears. The Bluetooth device acts on the trigeminal nerve, which is indirectly connected to the auditory system, and thereby blocks the transmission of unwanted impulses. The product is available on the market.

Tinnitus (or tinnite) is one of the most common diseases. Tinnit is noted in approximately 15% of the population, but the nature of this ailment makes it difficult to study and find treatment options. Neuromod Devices decided to create a Lenire device that combines trigeminal nerve neurostimulation to block tinnitus, and a hearing aid that extracts sounds that are in the required frequency range of a person's hearing from general noise.

Bluetooth device released that reduces tinnitus through neurostimulation of the tongue

The system consists of Bluetooth headphones and an electrode device that attaches to the tongue. The tongue attachment is designed to stimulate the trigeminal nerve at the desired frequencies at a power level so as not to cause pain and other unpleasant sensations. Each therapy session lasts less than an hour, during which the patient with tinnite listens to different sounds in the headphones and slightly protrudes his tongue, to the tip of which a neurostimulator is attached.

The Lenire system study involved more than 300 people with tinnite. Researchers showed that tinnitus symptoms decreased in more than 80% of participants. Moreover, after a year of follow-up, 80% of patients still showed significant improvement in hearing without pronounced symptoms. Although such technologies have already been used in the past, such a significant and prolonged improvement in neurostimulation is noted for the first time.^[2]

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