• Second large-scale trial shows greater reduction in tinnitus symptom severity using bimodal neuromodulation device, Lenire®
• 91% of treatment compliant participants experienced improvement in tinnitus symptoms that sustained 12 months after treatment
• 87.8% said they would recommend treatment to others with tinnitus
• Hør AS expands availability of Lenire in Norway by opening additional clinics

Oslo, Norway: – Neuromod Devices Limited, the medical device company specialising in the treatment of tinnitus, has published the results of the company’s TENT-A2 (Treatment Evaluation of Neuromodulation for Tinnitus – Stage A2) clinical trial in the highly regarded scientific journal, Nature – Scientific Reports in a paper titled: ‘Different bimodal neuromodulation settings reduce tinnitus symptoms in a large, randomized trial’.

The full paper is available here: TENT-A2 results¹.

Tinnitus, commonly referred to as ‘ringing in the ears’ is thought to affect between 10 – 15% of the global adult population^2,3. This could mean that 650,000 people in Norway experience tinnitus.

The TENT-A2 trial, which included 191 participants, is the company’s second large-scale clinical trial and sought to replicate and further enhance the results demonstrated in the company’s TENT-A1 trial, a study that evaluated the safety and efficacy of Lenire®, the company’s non-invasive bimodal neuromodulation device in 326 participants. The publication of the TENT-A2 results in Nature – Scientific Reports follows on from the publication of the TENT-A1 results as the cover story in Science – Translational Medicine in 2020 (the full TENT-A1 results paper is available here: TENT-A1 results)⁴.

The TENT-A2 study demonstrated that changing the treatment stimuli patients received halfway through treatment resulted in a greater proportion of treatment-compliant participants reporting an improvement in their tinnitus symptom severity as well as treatment-compliant participants reporting a greater average improvement in their tinnitus symptom severity compared to the TENT-A1 study^1,4,5, during which participants were treated with the same stimuli for the entire 12-week treatment period.

In the TENT-A1 study, treatment compliant participants demonstrated a mean improvement that was more than twice the published clinically important improvement^4,5. In the TENT-A2 study, 95% of treatment compliant participants reported an improvement in their symptom severity after 12 weeks of treatment^1,5. They reported a mean improvement that was almost three times the published clinically important improvement^1,5. 91% of treatment compliant participants achieved an improvement that sustained 12 months after treatment concluded^1,5.

Due to the results of TENT-A2, clinicians treating patients in the real-world have a body of evidence to support them changing the stimuli Lenire provides to patients during their follow-up visits in order to achieve a better treatment outcome resulting in greater improvement in patients’ tinnitus symptoms severity.

The tinnitus treatment device that was used in the studies, known as Lenire and available commercially in Norway from private clinic Hør AS, was developed by Neuromod. It is a bimodal neuromodulation device, stimulating nerves with two paired stimuli for therapeutic purposes. It consists of wireless (Bluetooth®) headphones that deliver sequences of audio tones to both ears, combined with electrical stimulation pulses delivered to the surface of the tongue via 32 electrodes on a proprietary device trademarked as Tonguetip®.

The timing, intensity and delivery of the stimuli are controlled by an easy-to-use handheld controller that each participant is trained to use prior to continuing treatment from home. Before using the treatment for the first time, the device is configured to the patient’s hearing profile and optimised to the patient’s sensitivity level for tongue stimulation. The device’s settings can be configured to provide treatment with different combinations of audio and electrical stimuli. Changing these combinations of stimuli after the first six weeks of treatment in TENT-A2 was the breakthrough which demonstrated a greater proportion of compliant participants reporting a greater average improvement in their tinnitus symptoms^1,4,5.

Similarly to TENT-A1, participants in the TENT-A2 trial were instructed to use Lenire for 60 minutes each day for 12 weeks. However, after an initial six weeks of treatment, the timing and delivery of the audio and tongue stimuli were changed for participants of the TENT-A2 trial for their remaining six weeks of treatment.

When treatment was completed, participants returned their devices and were assessed at three follow-up appointments up to 12 months. 70.3% of the 172 participants who filled out the exit survey said they had benefited from using the treatment and 87.8% said they would recommend other people with tinnitus to try the treatment¹. Further information about the trial and its criteria can be found using identifier NCT03530306 at https://www.clinicaltrials.gov.

Earlier in 2022, Lenire was made available in Norway via an exclusive partnership between Neuromod and Hør AS, Norway’s largest private provider of hearing healthcare and tinnitus care. Since the introduction of Lenire as a treatment option for tinnitus in their clinics, Hør have expanded their services in Norway by opening two new clinics in Trondheim and Sandefjord to meet the needs of the country’s tinnitus population.

Speaking on the news, Dr Ross O’Neill, Founding CEO of Neuromod said, “We’re delighted to announce the publication of positive results from the TENT-A2 clinical trial which show greater improvement in tinnitus symptom severity from treatment with Lenire. Tinnitus remains one of the largest unmet clinical needs both globally and specifically in Norway. I’m proud that Neuromod is at the forefront of developing bimodal neuromodulation technology to treat chronic tinnitus. Publishing two large-scale clinical trials in internationally recognised peer-reviewed journals with positive results for a tinnitus treatment device is a historic milestone. We’re committed to continuing our research to further improve patient outcomes and to partnering with specialist providers of tinnitus care such as Hør who share our vision for helping tinnitus patients with evidence-based interventions”.

Janne Hallset Mykkelbost, CEO at Hør commented, “As a tinnitus clinic which offers Lenire, the publication of positive peer-reviewed results from a second large-scale clinical trial is extremely encouraging. It shows a growing body of evidence that Lenire can help people with tinnitus and is consistent with the successful patient outcomes we’re seeing with our patients since introducing Lenire earlier this year”.

“We’re determined to expand the care we can provide to people living with tinnitus in Norway and we’re demonstrating this by expanding our services and opening two new clinics in Trondheim and Sandefjord”, continued Mykkelbost.

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 molded earplugs. The organisation has four private clinics in Norway, two of which recently opened in 2022.

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 Lenire

Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in a large-scale clinical trial⁴. 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.

About Nature – Scientific Reports

Scientific Reports is an open access journal publishing original research from across all areas of the natural sciences, psychology, medicine and engineering and a member of the Nature family of research journals. Scientific Reports is the 6th most-cited journal in the world, with more than 540,000 citations in 2020⁶, and receives widespread attention in policy documents and the media.

References

¹ Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://doi.org/10.1038/s41598-022-13875-x(2022)

² Baguely et al., Tinnitus, The Lancet (2013), https://www.sciencedirect.com/science/article/pii/S0140673613601427

³ McCormack, A., Edmondson-Jones, M., Somerset, S. & Hall, D. A systematic review of the reporting of tinnitus prevalence and severity. Hear Res. 337, 70–79. https://doi.org/10.1016/j.heares.2016.05.009(2016).

⁴ Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

⁵ As measured by Tinnitus Handicap Inventory (THI)

⁶ 2020 Journal Citation Reports® Science Edition (Clarivate Analytics, 2021)