Bimodal Neuromodulation for Tinnitus

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

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

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

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device for people with tinnitus, the annoying ringing or buzzing in the ears. The device employs bimodal neuromodulation, avoiding the specific pitch of the tinnitus sound to enhance comfort. Participants will use the device at home for one hour daily over 12 weeks, with virtual follow-ups. It suits those with non-pulsing tinnitus for 3 months to 20 years who can access the internet for virtual check-ins. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve tinnitus management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've started, stopped, or changed the dosage of certain medications like antidepressants, anticonvulsants, neuroleptics, or opioid analgesics in the past 3 months.

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

Previous studies have found that bimodal neuromodulation, which combines sound therapy with gentle electrical stimulation on the tongue, is safe. Research shows that this treatment is effective and well-tolerated, with no serious side effects reported. The Lenire device, used for this treatment, proved to be safer and more effective than sound therapy alone for individuals with moderate or worse tinnitus. These findings suggest that the treatment is generally safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard tinnitus treatments that often focus on masking sounds or using medication to manage symptoms, bimodal neuromodulation is unique because it combines auditory and sensory stimulation. This approach targets the brain's neural pathways that contribute to tinnitus, potentially offering a more direct method to alter the condition's underlying mechanisms. Researchers are excited about this treatment because it allows for personalized therapy by customizing the stimulation to the individual's dominant tinnitus frequency, which could lead to more effective and enduring relief. Plus, the convenience of at-home use makes it accessible and user-friendly, encouraging consistent treatment adherence.

What evidence suggests that this bimodal neuromodulation device is effective for tinnitus?

Research has shown that bimodal neuromodulation, which combines sound therapy with gentle electrical stimulation on the tongue using a device like Lenire®, effectively treats tinnitus. In studies involving over 500 patients, this treatment proved safe and effective. Specifically, 91.5% of patients reported a significant reduction in tinnitus symptoms after 12 weeks. On average, patients experienced an improvement in their condition, underscoring the treatment's potential. This trial will test a customized version of bimodal neuromodulation, where participants will use a device at home for one hour per day over a 12-week period. These findings suggest that bimodal neuromodulation could be a promising option for those dealing with tinnitus. ^{6 7 8 9 10}

Who Is on the Research Team?

Lei Feng

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for individuals experiencing tinnitus, a condition characterized by the perception of noise or ringing in the ears. Participants should be comfortable using a device that delivers bimodal stimulation customized to avoid their specific tinnitus pitch and willing to engage in virtual follow-ups.

Inclusion Criteria

Ability to read and understand English

Willing to commit to the full duration of the investigation

Baseline Tinnitus Handicap Inventory (THI) score from 38 to 100

Exclusion Criteria

I use benzodiazepines or sedative hypnotics.

History of auditory hallucinations

Participant with a pacemaker or other electro-active implanted device

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Training

Eligible participants are trained to use the bimodal stimulation device

1 day

1 visit (in-person)

Treatment

Participants use the bimodal stimulation device at home for one hour per day, in two 30-minute sessions, for 12 weeks

12 weeks

Home-based, no in-person visits required

Follow-up

Virtual follow-up assessments and/or phone calls to monitor compliance and satisfaction

12 weeks

Virtual follow-ups

What Are the Treatments Tested in This Trial?

Interventions

• Bimodal Neuromodulation

Trial Overview The study is testing a device providing bimodal neuromodulation with sound stimuli tailored to each participant's tinnitus pitch. The goal is to see if avoiding the tinnitus pitch increases comfort and satisfaction with the device compared to standard treatments.

How Is the Trial Designed?

Group I: Customized Bimodal Stimulation Experimental Treatment 1 Intervention

The study consists of one device per participant and is completed at home by the participant. Participants will be asked that bimodal stimulation is completed for one hour per day, in two 30-minute sessions every day, for the 12-week period. Eligible participants who consent to the study will be trained to use the device at ENROLLMENT. The 12-weeks of stimulation will consist of synchronized bimodal stimulation in which the participants' dominant tinnitus frequency will be removed from the stimulation setting via a programmed notched filter setting. A FINAL visit will be scheduled approximately 12-weeks from ENROLLMENT. Participants will be required to return their device at this visit.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

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

Retrospective chart review demonstrating effectiveness of ... Bimodal neuromodulation combining sound therapy with electrical tongue stimulation using the Lenire® device is emerging as an effective treatment for tinnitus.

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

Retrospective chart review demonstrating effectiveness of ... Bimodal neuromodulation combining sound therapy with electrical tongue stimulation using the Lenire® device is emerging as an effective treatment for tinnitus.

3. medrxiv.org medrxiv.org/content/10.1101/2024.08.22.24312175v2.full-text

Effectiveness of bimodal neuromodulation for tinnitus ... Of 212 patients with available data, there was a high responder rate of 91.5% (95% CI: 86.9%, 94.5%) with a mean improvement of 27.8 ± 1.3 (SEM) ...

4. med.umn.edu med.umn.edu/ent/news/sonic-lab-advancing-tinnitus-treatment-through-bimodal-neuromodulation

SONIC Lab - Advancing Tinnitus Treatment through ... Supported by three clinical trials involving over 500 patients, Lenire has demonstrated exceptional safety, efficacy, and patient compliance, ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12037789/

Retrospective chart review demonstrating effectiveness of ... Bimodal neuromodulation combining sound therapy with electrical tongue stimulation using the Lenire® device is emerging as an effective treatment for tinnitus.

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

Combining sound with tongue stimulation for the treatment ... The positive clinical efficacy and safety outcomes for the Lenire bimodal treatment, which was further supported by consistent real-world data ...

8. lenire.com lenire.com/

Lenire ® - Tinnitus Treatment Using Bimodal ... Lenire's dual mode stimulation has been proven safe and more effective than sound-only therapy for moderate or worse tinnitus.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT07092033

Assessment of Customized Bimodal Stimulation for Tinnitus The research objective of the proposed usability study is to assess the compliance and acceptance/satisfaction of using a bimodal stimulation device with the ...

10. brainstimjrnl.com brainstimjrnl.com/article/S1935-861X(22)00028-6/fulltext

Real-world clinical experience with bimodal neuromodulation ... Here, we present real-world data for the Lenire treatment at HörSys GmbH, a tinnitus treatment provider in partnership with the Hearing Center ...