What are Clinical Trials?
A clinical trial is a type of study which involves research using human participants with the intention to build and develop medical knowledge in a particular field, such as tinnitus. These trials further our understanding of medical treatments, diagnoses, the prevention of diseases or conditions, and more.
Many clinical trials are sponsored by pharmaceutical, biotech, or medical device companies to test the efficacy of a new device or drug. They’re widely regarded as the most responsible method of developing new medical interventions from initial research to widespread use in patients.
During clinical trials, participants receive different medical interventions (i.e. devices or drugs) which are applied under the supervision of medical or research experts. This team of experts monitor participants closely to watch out for how individuals react to the intervention.
For example, in our TENT-A1 trial, 326 participants were issued with a Lenire device for use during a 12-week treatment period. Trials are led by a principal investigator (PI) and the PI’s research team are all qualified healthcare professionals or experts in a particular field of science.
Why are Trials Important for Medical Devices?
When a medical device like Lenire is developed, clinical trials ensure that the device is effective and safe to use for patients. Research teams measure various outcomes in each participant of the trial.
Such trials allow researchers to determine if an intervention can make people feel better or stops a certain condition worsening in a patient. They also determine if a patient, or a certain type of person, is likely to suffer any side effects from use of the device.
Most importantly, clinical trials ensure that the treatment is safe for use by the public. Regulatory bodies worldwide require a high standard of clinical trial results before they approve new medical devices for use.
Peer Reviewed Research
Publication of medical research conducted during a clinical study is important as it acknowledges the scientific accuracy and validity of the research. This allows healthcare professionals to trust the scientific information that has been published about the treatment or condition which was investigated and ultimately helps the adoption of new medical practices.
During the peer review process, the findings of a clinical trial are put under the scrutiny of independent experts in the same field of medicine and research as the trial organisers. These experts validate and evaluate the claims made in the study, as well as its methodologies, and judge if it is suitable for publication in a medical journal.
TENT-A2 Research Paper:
Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial
Published on: 30/06/2022 Corresponding author: Hubert Lim Download.pdf (3.97 MB)
TENT-A2 Protocol Paper:
Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters
Published on: 01/09/2019 Corresponding author: Hubert Lim Download.pdf (556.43 KB)
TENT-A1 Research Paper:
Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study (2020)
Published on: 07/10/2020 Corresponding author: Hubert Lim Download.pdf (1.68 MB)
TENT-A1 Supplementary Materials:
Supplementary Materials for Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study
Published on: 07/10/2020 Corresponding author: Hubert Lim Download.pdf (3.06 MB)
TENT-A1 Protocol Paper:
Bi-modal stimulation in the treatment of tinnitus: a study protocol for an exploratory trial to optimise stimulation parameters and patient subtyping.
Published on: 08/11/2017 Corresponding author: Shona D’Arcy Download.pdf (647.72 KB)
TAVSS Research Paper:
An Investigation of Feasibility and Safety of Bi-Modal Stimulation for the Treatment of Tinnitus: An Open-Label Pilot Study
Published on: 04/02/2016 Corresponding author: Caroline Hamilton Download.pdf (117.62 KB)Clinical Trials of Lenire
95%
95% of compliant TENT-A2 participants demonstrated an improvement in tinnitus symptom severity when evaluated after 12 weeks of treatment
91%
91% of compliant TENT-A2 participants experienced continued improvement in tinnitus symptom severity when evaluated at 12-months post-treatment.
500+
Lenire has shown to reduce the symptoms of tinnitus in clinical trials involving more than 500 participants
Since 2015, Neuromod Devices has conducted clinical trials with Lenire’s bimodal neuromodulation technology. To date, more than 500 patients have enrolled in trials across Ireland and Germany. These studies took place at St. James’ Hospital, Dublin in Ireland and at the Tinnitus Centre, University Hospital Regensburg, Germany. The results have been very positive.
Treatment Evaluation of Neuromodulation for Tinnitus Stage 2 (TENT-A2)
Double-Blinded Randomized Trial
2019, 191 participants
In TENT-A2, optimised settings of Lenire were applied. Preliminary results are consistent with TENT-A1 and show a higher proportion of patients. The results are currently being peer-reviewed for publication.
Treatment Evaluation of Neuromodulation for Tinnitus Stage 1 (TENT-A)
Double-Blinded Randomized Trial
2017, 326 participants
TENT-A1 has shown that Lenire is effective in reducing tinnitus symptoms in a large cross section of tinnitus patients.
Tinnitus Alleviation Via Sensory Stimulation (TAVSS)
Safety and Feasibility Study
2015, 60 participants
The safety and feasibility study was designed to assess the safety of treatment prior to proceeding to large scale clinical trials.
Real-world evidence
Real-world data of patients’ treatment outcomes with Lenire is consistent with the outcomes of Neuromod’s large-scale clinical trial, TENT-A1. An independent analysis of real-world patients of Lenire has demonstrated its ability to reduce the symptoms of tinnitus.
The data analysis of the effectiveness of Lenire for real-world patients was conducted at the German Hearing Center (DHZ) at Hannover Medical School in Germany.
This study showed that six to 12 weeks of treatment using Lenire can safely achieve clinically meaningful improvements in tinnitus symptom severity in a real-world clinical setting. The results of this study were published in the journal, Brain Stimulation in February 2022.
85% of patients achieved an improvement in their tinnitus symptoms, as measured by Tinnitus Handicap Inventory.
Retrospective Analysis of Real-World Patients:
Real-world clinical experience with bimodal neuromodulation for the
treatment of tinnitus.
Additional Resources
Access additional resources and coverage of our clinical trials produced by scientific media and Neuromod:
- 30/06/2022TENT-A2 Results Infographic
- 23/05/2022Usability of Bimodal Neuromodulation to Treat Tinnitus
- 07/09/2020TENT-A1 Results Infographic
- 04/08/2020www.scientificamerican.com – Scientific American’s coverage
- 24/04/2020www.newscientist.com – New Scientist’s coverage
Healthcare Professionals
If you are a healthcare professional involved or interested in treating tinnitus and would like to learn more about how to incorporate Lenire into your practice, visit our dedicated healthcare professionals’ page.
