Neuromod Devices received US FDA 510(k) De Novo approval for its first non-invasive Lenire® bimodal neuromodulation device in March 2023. Credit: Neuromod Devices.
Neuromod has made an agreement with Tinnitus Klinika to make Lenire® device available in Hungary. Credit: Neuromod Devices.
The clinical trial TENT-A2 found that Lenire® was effective for 95% patients in reducing tinnitus symptoms, with zero adverse events reported. Credit: Neuromod Devices.

Lenire® is a non-invasive bi-modal neuromodulation device developed by Neuromod Devices, a medical technology company based in Ireland, for the treatment of tinnitus.

Commonly called ringing in the ears, tinnitus is a complex neurological condition that creates a perception of sound without any external source. It can have a significant impact on a person’s quality of life, causing stress, anxiety and depression. An estimated 25 million people in the US are living with tinnitus.

The British Tinnitus Association approximates that more than seven million individuals experience the condition in the UK. An estimated 10% to 15% of the adult population globally is affected.

Lenire device approval and availability

The Lenire® device is CE-marked in Europe and is available by prescription through a network of audiologists and hearing healthcare professionals.

The Tinnitus Clinic’s network of seven locations across the UK, including London, Bristol, Leeds, Leicester, Manchester, Newcastle and Stirling, offers the Lenir® device to tinnitus patients. They can also be received online through the company’s Neuromod Medical tinnitus telemedicine service.

The company launched the Otologie tinnitus telemedicine service at its clinic in Dublin, Ireland, for tinnitus patients from where it prescribes a range of proven treatments, including Lenire® to them.

Neuromod Devices collaborated with HØR, a private provider of hearing and tinnitus care based in Norway, to make the Lenire® tinnitus treatment device available in Norway in May 2022.

The device was made available in Hungary by partnering with Tinnitus Klinika, a provider of specialist tinnitus care based in Hungary, in September 2022. Lenire® is available in several other European countries such as Switzerland, Austria, Germany and Belgium.

The US Food and Drug Administration (FDA) granted De Novo approval for the device in March 2023.

Lenire device design

Lenire® is a combined acoustic and electrical intraoral stimulation device comprising three main components: a controller, a Tonguetip® and Bluetooth® headphones.

The controller enables patients to adjust the duration and intensity of the treatment. The Tonguetip® is a proprietary intraoral device designed to sit comfortably in the closed mouth. A small electrode in the Tonguetip® is placed on the patient’s tongue that triggers nerves by delivering a gentle electrical stimulation on the tongue’s surface.

The Bluetooth® headphones play personalised sounds to the ear, which are aimed at stimulating the auditory nerve.

Working of Lenire

Lenire® delivers two types of stimulation to the auditory system: sound stimulation and tongue stimulation.

Sound stimulation, delivered through Bluetooth® headphones and tongue stimulation through the Tonguetip®, work together to provide a unique sensory experience that can help to re-train the brain and reduce the perception of tinnitus.

Sound stimulation helps to invigorate the auditory system, whereas tongue stimulation activates the trigeminal nerve, which is connected to the auditory system.

The device is used for 60 minutes a day for a minimum of 12 weeks. The timing, intensity and synchronisation of the sound and tongue stimuli are controlled by the handheld controller. Furthermore, the treatment session can be started, paused and resumed by the controller, as well as the volume of the sound can be adjusted.

Funding details for the Lenire device

Neuromod Devices raised €10.5m ($12.3m) during a Series B financing round in October 2020. The funding is being used to scale up manufacturing and expand the commercial presence of the Lenire® device in Europe. The round was led by Fountain Healthcare Partners, an Irish venture capital company and saw participation from existing investors Moffett Investment and Medical Device Resources. Additionally, Kreos Capital and Silicon Valley Bank provided venture debt as part of the financing.

Moreover, in April 2023, the company closed the Series B2 funding round, raising €30m ($32.8m), which will be utilised to further market and launch the Lenire® device in the US. The round was primarily led by new investors Panakes Partners, a venture capital company based in Milan and the European Investment Bank. Existing investor Fountain Healthcare Partners also participated in the funding round.

Clinical trials on Lenire

Clinical trials on Lenire® have shown that the device can effectively reduce the severity of tinnitus symptoms and improve the overall quality of life for many patients.

The FDA approval of the device was based on Lenire®’s third large-scale clinical trial, TENT-A3, which was supported by confirmatory Real-World Evidence from 204 patients.

Out of 204 patients, 79.4% of the patients experienced a clinically significant improvement in their condition, 82.4% were compliant with the treatment and 88.6% recommended Lenire® as a tinnitus treatment. Lenire® was also found to be safe to use with no serious adverse events.

The TENT-A3 trial was built on the positive results of the previous two trials, namely TENT-A1 and TENT-A2, that together enrolled more than 500 patients.

The data from the TENT-A1, TENT-A2 and TENT-A3 clinical trials consistently demonstrated the efficacy, safety and compliance of Lenire®. When combined, these trials have showcased the effectiveness and inherent safety of Lenire® in more than 600 patients participating in the clinical studies.