Bimodal Stimulation Device for Tinnitus

Overseen By Yezihalem Mesfin, MSE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Antidepressants, Anticonvulsants, Neuroleptics, Opioids

Disqualifiers: Meniere's, Hyperacusis, Epilepsy, Schizophrenia, TMJ, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well individuals with tinnitus (ringing in the ears) can use and are satisfied with a new version of the Lenire bimodal stimulation device. The device combines sound through headphones with gentle electrical tingling on the tongue to alleviate tinnitus symptoms. The study focuses on enhancing the device's usability from home, eliminating the need for an in-person hearing test. Individuals with non-pulsing tinnitus for 3 months to 20 years who can manage virtual appointments might be suitable candidates for this trial. As an unphased study, this trial offers participants the chance to contribute to innovative research that could enhance home-based tinnitus treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have started, stopped, or changed the dosage of certain medications like antidepressants, anticonvulsants, neuroleptics, or opioid analgesics in the past 3 months, you may not be eligible to participate.

What prior data suggests that this bimodal stimulation device is safe for tinnitus treatment?

Research shows that the Lenire device is safe for treating tinnitus. Studies have found it can be used without causing serious side effects. The device combines sound with gentle electrical stimulation on the tongue. In real-world settings, this treatment has been used for six to 12 weeks, helping many people significantly reduce their tinnitus symptoms. Most patients have tolerated it well, with high satisfaction and compliance rates. Lenire has received FDA approval for its safety in treating tinnitus. For those considering joining a trial, the safety data from previous studies appears promising. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Lenire bimodal stimulation device is unique because it targets tinnitus through both auditory and somatosensory pathways. Unlike standard treatments like sound therapy, cognitive behavioral therapy, or medications, Lenire combines gentle electrical stimulation to the tongue along with audio stimulation via headphones. This dual-action approach aims to reduce tinnitus symptoms more effectively by engaging multiple sensory systems, which is why researchers are excited about its potential. Additionally, the device allows users to adjust headphone volume for comfort, offering a personalized treatment experience.

What evidence suggests that the Lenire bimodal stimulation device is effective for tinnitus?

Research has shown that the Lenire device, used by participants in this trial, helps reduce tinnitus symptoms. In one study, 91.5% of patients noticed a significant improvement in their tinnitus after using it for 12 weeks. Real-world results from Germany also support these positive outcomes. Lenire combines sound with gentle electrical signals to the tongue, which has been shown to calm tinnitus. These findings confirm that Lenire is a safe and effective way to manage tinnitus symptoms. ^{1 3 6 7 8}

Who Is on the Research Team?

Peggy Nelson, PhD

Principal Investigator

University of Minnesota

Meredith Adams, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

Adults over 18 with chronic subjective tinnitus for 3-20 years, a specific Tinnitus Handicap Inventory (THI) score range, and varying degrees of hearing loss can join. They must read English, consent to the study's duration, have internet access for virtual visits/surveys, and not be involved in other tinnitus studies or treatments.

Inclusion Criteria

I have hearing loss.

Willing and able to provide and understand informed consent

My tinnitus has lasted for more than 3 months but less than 20 years.

Exclusion Criteria

I haven't changed my medication for depression, seizures, psychosis, or pain in the last 3 months.

I use benzodiazepines or sedative hypnotics.

You have been diagnosed with psychosis or schizophrenia in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants use the Lenire device for 60 minutes daily for 12 weeks, with adjustments to the headphone volume allowed

12 weeks

1 visit (in-person), mostly virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Lenire bimodal stimulation device

Trial Overview The Lenire bimodal stimulation device is being tested for user compliance and satisfaction without needing an audiogram fitting. It delivers sound to ears via headphones and electrical stimulation to the tongue. Participants use it daily for at least 10 weeks mostly through virtual visits.

How Is the Trial Designed?

Group I: Single study arm Experimental Treatment 1 Intervention

The Lenire device is CE marked in Europe and intended to reduce the symptoms of tinnitus. It comprises a handheld controller and an intra-oral device called a Tonguetip® Intra-Oral Device (IOD), which delivers gentle electrical stimulation to the tongue, and also comprises of a set of wireless consumer headphones that deliver audio stimulation. The sound and tongue stimulus parameters such as stimulus rate, stimulus intensity, and the timing relationship between the auditory and somatosensory stimulus events are grouped into stimulation Parameter Sets (PS). PS1 is used during the first 6-weeks of stimulation and PS4 is used during the second 6-weeks of stimulation, similar to what is routinely used for tinnitus individuals in Europe. For this study, the device software has been modified to allow users to adjust the headphone volume to a level that is comfortable and clearly audible instead of a preset volume with limited adjustments based on the patient's audiogram.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Neuromod Devices Limited

Collaborator

Trials

1

Recruited

50+

Kent Taylor

Collaborator

Trials

1

Recruited

50+

Citations

1. nature.com nature.com/articles/s43856-025-00837-3

Retrospective chart review demonstrating effectiveness of ... Conclusions. These findings show that the Lenire device can be used to safely and effectively reduce tinnitus in a real-world clinical setting.

2. lenire.com lenire.com/lenire-real-world-evidence-published-nature-communications-medicine/

Lenire Real World Evidence Published in Nature Comms ... After 12-weeks 91.5% of patients had a clinically meaningful reduction in tinnitus. This demonstrates the effectiveness of a typical treatment ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40295853/

Retrospective chart review demonstrating effectiveness of ... Conclusions: These findings show that the Lenire device can be used to safely and effectively reduce tinnitus in a real-world clinical setting.

4. lenire.com lenire.com/the-science-of-lenire/

How Can Neuromodulation Treat Tinnitus: The Science of ... Lenire is a dual mode stimulation device that is proven to soothe tinnitus. · How Lenire Soothes Tinnitus · TENT-A2 Results: Sustained Relief for 91% of Patients ...

5. nature.com nature.com/articles/s41467-024-50473-z

Combining sound with tongue stimulation for the treatment ... Recently published real-world data collected in Germany also showed consistent positive outcomes in tinnitus symptoms with Lenire bimodal ...

6. lenire.com lenire.com/hannover-lenire/

Real-world evidence demonstrates the safety and efficacy ... This study showed that six to 12 weeks of treatment using Lenire's sound and electrical stimulation of the tongue can safely achieve clinically meaningful ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11333749/

Combining sound with tongue stimulation for the treatment ... There are no device related serious adverse events. These positive outcomes led to FDA De Novo approval of the Lenire device for tinnitus ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05227365

Treatment Evaluation of Neuromodulation for Tinnitus TENT-A3 is a single arm repeated measures prospective investigation evaluating the safety and efficacy of the Lenire device for tinnitus treatment.