91% of Compliant Patients Report Long Term Tinnitus Relief in Large Scale Clinical Trial.

• Changing audio tones and electrical stimulation during treatment shows greater reduction in tinnitus symptoms severity during second large-scale trial using bimodal neuromodulation device, Lenire®
• 91% of treatment compliant participants experienced improvement in tinnitus symptoms that sustained 12 months after treatment.
• 95% of treatment compliant participants reported an improvement in tinnitus symptoms in as little as 6 weeks.
• 87.8% said they would recommend treatment to others with tinnitus
• Lenire is the first commercially available bimodal neuromodulation device which treats tinnitus. Lenire is available in Denmark through Specialklinikken Borgå ApS.

Neuromod Devices Limited, the medical technology company behind the novel tinnitus treatment device, Lenire^®, published overwhelmingly positive results of the breakthrough device’s second large-scale clinical trial, TENT-A2 (Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2)¹.

The trial found that changing the audio and electrical stimuli Lenire^® provided patients during treatment could result in significant further improvement in the severity of their tinnitus symptoms¹.

The TENT-A2 Clinical Trial found that 91% of compliant patients had a long-term reduction in tinnitus symptoms¹. This proven effectiveness offers hope to the 10 – 15% of the global adult population, potentially 650,000 people in Denmark, who suffer from tinnitus^2,3.

“We’re delighted to announce the publication of positive results. These results 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 Denmark. I’m proud that Neuromod is at the forefront of developing technology to treat chronic tinnitus.” said Neuromod Founder and CEO, Dr. Ross O’Neill.

Lenire^®, the subject of the TENT-A2 Trial, is a non-invasive bimodal neuromodulation device used to treat the symptoms of tinnitus, a condition that is commonly known as ‘ringing in the ears’.

TENT-A2 included 191 participants and sought to build upon and enhance the success reported in the TENT-A1 Clinical Trial, a study that evaluated the safety and efficacy of Lenire^® in 326 participants. TENT-A1 results were so significant they were published as the cover story in Science – Translational Medicine in 2020. Read the TENT-A1 results⁴.

Full TENT-A2 results were published in Nature – Scientific Reports in a paper titled ‘Different bimodal neuromodulation settings reduce symptoms in a large, randomised trial’ and is available here:TENT-A2 results¹.

Lenire^® 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^®.

TENT-A2 showed that changing the audio tones and electrical stimulation halfway through treatment leads to a higher average improvement in symptom severity and more compliant patients reporting positive results when compared to TENT-A1^1,4,5. While both studies asked patients to use Lenire^® for 1-hour per day for 12-weeks, TENT-A1 did not modify stimuli during treatment⁴.

The TENT-A1 study showed symptom severity improvements that were more than twice the published clinically significant improvement ^4,5. TENT-A2 showed that 95% of compliant participants reported a mean improvement in symptom severity that was on average nearly three times the clinically significant improvement after 12 weeks ^1,5.

Importantly, 91% of treatment compliant participants achieved an improvement that sustained for a minimum of 12 months after treatment concluded ^1,5.

The results of TENT-A2 are also consistent with an analysis of real-world Lenire^® patients carried out earlier in 2022. In the analysis 85% of compliant patients reported improvement in their tinnitus symptoms severity after 6 – 12 weeks of treatment ^5,6.

Earlier in 2022, Lenire^® was made available in Denmark via a partnership between Neuromod andSpecialklinikken Borgå ApS. A National Health Report published by The Danish National Health Authority in 2017 found the prevalence of tinnitus in the country to be 12.7%, a 25% increase from 10.1% in 2010, and that prevalence increased with increasing age⁷. Lenire^® provides an additional treatment intervention, which is backed by clinical trials, for Specialklinikken Borgå to consider for its tinnitus patients.

Thomas Borgå, owner and clinic manager at Specialklinikken Borgå ApS said: "Tinnitus is a disorder that impairs the quality of life for an enormous number of Danes, and unfortunately the common perception among Danes is that there is no treatment who can reduce tinnitus, and many patients therefore face left with frustrations and no of hope to of recovery.

We have for several years worked to offer tinnitus patients effective treatment, and we are therefore incredibly proud to now be able to offer tinnitus patients Lenire. Neuromod's TENT-A1 trial with Lenire® was a major landmark in tinnitus research, and the improvements shown in TENT-A2 are even more so encouraging. These research results provide real hope for people in Denmark who suffer from tinnitus, many of whom will be able to significantly reduce their tinnitus over time and achieve a significantly better quality of life.”

Further information about the trial and its criteria can be found using identifier NCT03530306 athttps://www.clinicaltrials.gov.

Connect with Neuromod Devices Ltd  

• LinkedIn:linkedin.com/company/neuromod 
• Twitter:twitter.com/NeuromodDevices 
• Neuromod Devices website:neuromoddevices.com
• Lenire website:lenire.com

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 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.

⁷ Danskernes Sundhed – Den Nationale Sundhedsprofil, Danish Health Authority, www.sst.dk

⁸ 2020 Journal Citation Reports® Science Edition (Clarivate Analytics, 2021)