Irish medical device company, Neuromod Devices, which specialises in the treatment of tinnitus has reached an agreement with HØR AS, Norway’s largest private provider of hearing and tinnitus care, to make its Lenire tinnitus treatment device available in Norway.

Lenire is a bimodal neuromodulation device which has shown in clinical trials to reduce the symptoms of tinnitus. Tinnitus, commonly known as “ringing in the ears”, is a complex neurological condition resulting in the perception of sound without an external source. It’s thought to affect 10-15% of the adult population globally which could mean up to 650,000 Norwegians are living with the condition.

Landmark research into the prevalence of tinnitus in Europe was published in The Lancet in late 2021. It found that prevalence significantly increased with increasing age and worsening of hearing status. It also found that healthcare resource use for tinnitus increased with increasing tinnitus symptom severity.

Through this agreement, HØR’s specialist audiology team has licence from Neuromod to provide Lenire for the treatment of tinnitus to suitable patients in their chain of private clinics throughout Norway. HØR’s flagship clinic is at Ullevål Stadion, with an additional inhouse clinic at Aleris Frogner. The organisation is expanding with two more clinics in Trondheim and Vestfold opening in the coming months.

Dr Ross O'Neill, founder and CEO of Neuromod Devices, said: “I’m delighted that by working with HØR we can make Lenire available to people living with tinnitus in Norway. Tinnitus remains a significant healthcare challenge but by partnering with clinical specialists like the team at HØR we can improve patient outcomes for people living with the condition.”

The agreement comes following Lenire’s launch in Spain in early 2022 and the publication of an independent real-world study demonstrating the safety and efficacy of the Lenire device for improving symptoms in tinnitus patients. The study found that 85% of tinnitus patients experienced a reduction in their tinnitus symptoms, as measured by THI, following six to 12 weeks of treatment using Lenire. The results were recently published in the scientific journal Brain Stimulation.

The device has also been used in large-scale clinical trials with over 500 patients. The first of these clinical trials, involving 326 participants, was published in October 2020 as the cover story in the internationally renowned journal Science Translational Medicine and reported improvements in patients’ tinnitus symptoms. 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms, measured by THI, after a 12-week treatment period. When followed up 12 months post treatment, 80.1% of these participants had sustained the improvements. This study represents one of the largest and longest followed-up clinical trials ever conducted in the field of tinnitus devices.

Janne Hallset Mykkelbost, CEO at HØR, said: “I’m delighted that HØR are partnering with Lenire so we can provide an evidence-based treatment option that has seen encouraging patient outcomes in large-scale clinical trials and in the real world. I’m looking forward to working with Neuromod closely as we open our new clinics in Trondheim and Vestfold so we can provide care to more people who are living with tinnitus.”

Lenire is a bimodal neuromodulation device which combines mild electrical pulses to the tongue with sound stimulation to drive neuroplasticity in the brain which reduces the symptoms of tinnitus. It has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe.

The device consists of Bluetooth headphones which play customised sounds to activate the auditory nerve, an intra-oral device which provides mild electrical stimulation to the surface of the tongue, known as a Tonguetip, and a controller which controls the duration and intensity of treatment with the device.

The device’s sound and electrical stimuli can be calibrated to suit a patient’s tinnitus after an initial assessment of their condition which includes an audiological exam. The supervising healthcare professional demonstrates how to use the device and provides the patient with instructions for use. Subsequently, patients use Lenire for 60 minutes per day typically for at least 10 weeks.