Country for PR: United Kingdom
Contributor: PR Newswire Europe
Thursday, June 30 2022 - 21:00
Neuromod Publishes Results of Second Large Scale Clinical Trial for Tinnitus in Top-Tier Scientific Journal, Shows Greater Improvement of Symptoms
DUBLIN, June 30, 2022 /PRNewswire-AsiaNet/ --

- Second large-scale trial shows greater reduction in tinnitus symptom severity 
using bimodal neuromodulation device, Lenire(R)
- 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

     Neuromod Devices Limited, the Irish 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 results 
[] [1]. 

     Tinnitus, commonly referred to as "ringing in the ears" is thought to 
affect between 10 – 15% of the global adult population[2,3]. 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(R), the company's non-invasive bimodal neuromodulation device in 326 

     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]. This second major 
publication continues Neuromod's strategy to establish the clinical credibility 
of bimodal neuromodulation through publishing large-scale clinical trials in 
top-tier peer-reviewed journals.

     The TENT-A2 study investigated if changing treatment stimuli after six 
weeks of treatment would result in greater improvement in tinnitus symptoms 
than observed in the TENT-A1 study, 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. In the TENT-A2 study, 95% of treatment compliant participants 
achieved a greater average improvement in symptoms compared to TENT-A1[1,4,5] 
and almost three times the published clinically important improvement. 91% of 
treatment compliant participants achieved an improvement that sustained 12 
months after treatment concluded[1,5].

     TENT-A2 is the second large-scale clinical trial validating the safety, 
with high patient satisfaction and tolerability, of bimodal neuromodulation as 
a treatment for tinnitus while also demonstrating greater efficacy in reducing 
tinnitus symptoms through optimised treatment regimens compared to the first 
large-scale trial.

     Bimodal neuromodulation is the stimulation of nerves with two paired 
stimuli for therapeutic purposes. The tinnitus treatment device that was used 
in the study, known as Lenire and available commercially throughout Europe, was 
developed by Neuromod. It consists of wireless (Bluetooth(R)) 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(R). The device's settings can be 
configured to provide treatment with different combinations of audio and 
electrical stimuli.

     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.

     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. In TENT-A1, the stimulation setting remained the same for 
the full 12 weeks of treatment. This change in treatment regimen resulted in a 
greater average reduction in tinnitus symptom severity achieved by treatment 
compliant participants[1,4,5].

     The study was conducted at the Wellcome Trust-HRB Clinical Research 
Facility, St. James's Hospital, Dublin, Ireland with no treatment-related 
Serious Adverse Events (SAEs) reported and a high treatment compliance. Out of 
191 enrolled participants, 83.8% used the device at or above the minimum 
compliance level over the 12-week treatment period[1].

     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 treatment[1].

     Participants were screened and selected based on a pre-defined list of 
inclusion and exclusion criteria that enrolled a representative sample of the 
wider tinnitus population. Further information about the criteria can be found 
using identifier NCT03530306 at

     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 symptoms from 
treatment with Lenire. Tinnitus remains one of the largest unmet clinical needs 
globally and 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, and we're committed to continuing our research in this area to 
further improve patient outcomes."

     Hubert Lim, Chief Scientific Officer at Neuromod, commented, "I am proud 
of our company's ability to build on our prior research by enrolling 191 
participants in another large-scale clinical trial that showed even greater 
improvements in tinnitus symptoms compared to our previous large-scale study 
when adjusting the stimulation regimen over time. The successful completion of 
two large-scale trials is a major milestone in our continuing work to develop a 
treatment to help as many people living with tinnitus and in further 
demonstrating bimodal neuromodulation as a safe and effective intervention for 
people living with the condition."

     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 

     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 

     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.

     Connect with Neuromod Devices Ltd:
     Neuromod Devices website: 
     Lenire website:

     1. Conlon et al., Different bimodal neuromodulation settings reduce 
tinnitus symptoms in a large  randomized trial, Sci Rep, (2022).
     2. Baguely et al., Tinnitus, The Lancet (2013),
     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. (2016).
     4. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020). 
     5. As measured by Tinnitus Handicap Inventory (THI). 
     6. 2020 Journal Citation Reports(R) Science Edition (Clarivate Analytics, 

     Photo -
     Photo -
     PDF -
     For more information, please contact: 
     Neil Doyle 
     Global Director of Marketing 
     Neuromod Devices
     +353 85 822 9021
     SOURCE: Neuromod Devices Ltd