Lenire®, the treatment device shown to reduce tinnitus symptoms in 86.2% of patients, is now available in Norway

Oslo, Norway: Irish medical device company, Neuromod Devices Ltd., 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 globallyⁱ 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 renowned scientific journal, 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 severityⁱⁱ.

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.

“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,” explains Dr Ross O'Neill, Founder and CEO of Neuromod Devices.

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 THIⁱⁱⁱ, following six to 12 weeks of treatment using Lenire^iv. The results were recently published in the highly ranked 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^v. When followed up 12 months post treatment, 80.1% of these participants had sustained the improvements^v. This study represents one of the largest and longest followed-up clinical trials ever conducted in the field of tinnitus devices.

“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,” explains Janne Hallset Mykkelbost, CEO at HØR.

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, a proprietary 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. Follow-up visits with the healthcare professional occur during treatment to monitor patients’ progress.

At the end of the prescribed treatment plan, the healthcare professional advises the patient about their continued use of Lenire.

ENDS

For more information please contact:

Neil Doyle

Global Director of Marketing,

Neuromod Devices

neil.doyle@neuromoddevices.com

 

Notes to Editor:

About Neuromod Devices Ltd

Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. Neuromod specialises in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions. The lead application of Neuromod’s technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. Neuromod’s tinnitus treatment device, Lenire, is currently available throughout Europe. For more information visit www.neuromoddevices.com.

About HØR

HØR is Norway’s largest private treatment centre for hearing healthcare and tinnitus. Founded in 2017, HØR’s team of audiological specialists provide care for hearing, hearing aids, tinnitus, reduced sound tolerance and moulded earplugs. The organisation has two private clinics in Norway with a further two clinics opening in 2022.

About Lenire

Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in a large-scale clinical trial. Lenire has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe. Further details about Lenire including a list of providers can be found at www.lenire.com.

References

(i)                 Baguely et al., Tinnitus, The Lancet (2013), https://www.sciencedirect.com/science/article/pii/S0140673613601427

(ii)                R. Biswas et al., Tinnitus prevalence in Europe: a multi-country cross-sectional population study, The Lancet Regional Health (2021), https://doi.org/10.1016/j.lanepe.2021.100250  

(iii)               THI or Tinnitus Handicap Inventory is a clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. Measured on a scale of 100, the higher the score, the greater the impact of tinnitus. Reducing a person’s THI score should correspond to improved quality of life by reducing how their tinnitus is affecting them.

(iv)              Buechner A, Lesinski-Schiedat A, Becker P, Lenarz T, Real-world clinical experience with bimodal neuromodulation for the treatment of tinnitus - A case series, Brain Stimulation (2022), doi: https://doi.org/10.1016/j.brs.2022.01.022.

(v)               Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)