PR96799

DUBLIN, June 30, 2022 /PRNewswire=KYODO JBN/ --

- 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

[https://www.neuromoddevices.com/tenta2] [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

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

[https://www.neuromoddevices.com/tenta1results])[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 https://www.clinicaltrials.gov.

     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 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.

     Connect with Neuromod Devices Ltd:

     LinkedIn: https://www.linkedin.com/company/neuromod/

     Twitter:  https://twitter.com/NeuromodDevices

     Neuromod Devices website: https://www.neuromoddevices.com/

     Lenire website: https://www.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. 2020 Journal Citation Reports(R) Science Edition (Clarivate Analytics,

2021).

     Photo - https://mma.prnewswire.com/media/1850706/Neuromod_Devices_1.jpg

     Photo - https://mma.prnewswire.com/media/1850705/Neuromod_Devices_2.jpg

     PDF - https://mma.prnewswire.com/media/1850707/Neuromod_Devices.pdf

     For more information, please contact:

     Neil Doyle

     Global Director of Marketing

     Neuromod Devices

     +353 85 822 9021

     neil.doyle@neuromoddevices.com

     SOURCE: Neuromod Devices Ltd