Lenire Device for Tinnitus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if the Lenire Device can help people with tinnitus (ringing in the ears) through bimodal stimulation, which combines sound and gentle electrical pulses. Researchers will measure changes in brain activity to assess the device's impact after six weeks of use. Participants will either use the device daily or join a control group that does not use it. Ideal candidates have experienced non-pulsing tinnitus for over three months but less than 20 years and can hear the device's sounds. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatments for tinnitus.
Will I have to stop taking my current medications?
If you've started, stopped, or changed the dosage of certain medications like antidepressants, anticonvulsants, neuroleptics, or opioid painkillers in the last 3 months, you might not be eligible for the trial. Also, if you use benzodiazepines or sedative hypnotics, you cannot participate.
What prior data suggests that the Lenire device is safe for tinnitus treatment?
Research has shown that the Lenire device, which combines sound with gentle tongue stimulation, is safe for people with tinnitus. Studies have found no serious side effects related to the device. This strong safety record contributed to its FDA approval for treating tinnitus. More than 500 people have used the device in large trials, experiencing benefits with minimal risk. Overall, these results suggest the treatment is well-tolerated.12345
Why are researchers excited about this trial?
Researchers are excited about the Lenire device for tinnitus because it offers a novel approach called bimodal stimulation, which combines sound with mild electrical pulses to the tongue. Unlike traditional treatments like sound therapy alone or medication, this dual-action method aims to retrain the brain’s response to tinnitus more effectively. This innovative delivery method has the potential to provide relief in a non-invasive and drug-free way, making it a promising option for those who haven't found success with existing treatments.
What evidence suggests that the Lenire device is effective for tinnitus?
Research has shown that the Lenire device, which uses a special type of stimulation, significantly reduces tinnitus symptoms. In this trial, participants in the treatment group will use the Lenire device for 1 hour daily. After six weeks of treatment, 78% of users in previous studies reported a noticeable decrease in their tinnitus. This improvement increased to 91.5% after 12 weeks of use. Another study found that 80.1% of participants who continued the treatment experienced ongoing improvement even a year later. These findings suggest that the Lenire device effectively reduces the ringing or buzzing in the ears for many people.12678
Who Is on the Research Team?
Peggy Nelson
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for individuals with tinnitus, a condition characterized by the perception of noise or ringing in the ears. Participants will be using a device called Lenire that provides bimodal stimulation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the Lenire device for 1 hour daily for six weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bimodal Stimulation
Trial Overview
The study aims to determine if EEG-based brain entropy and auditory brainstem responses can objectively measure improvements in tinnitus after six weeks of using the Lenire device.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Use Lenire device for 1 hour daily
Participants in the control group will not receive the stimulation device and will not undergo any stimulation during the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Citations
Lenire Real World Evidence Published in Nature Comms ...
After an interim check-up after six weeks of treatment with Lenire, 78% had a clinically meaningful reduction in tinnitus. After 12-weeks 91.5% ...
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.
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.
Neuromod publishes results of Lenire large-scale tinnitus ...
80.1% of treatment compliant participants experienced continued improvement in tinnitus symptom severity when evaluated 12-months post-treatment. Neuromod ...
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) ...
Sound + Tongue Stimulation for Tinnitus Treatment Trial
There are no device related serious adverse events. These positive outcomes led to FDA De Novo approval of the Lenire device for tinnitus ...
Effectiveness of bimodal neuromodulation for tinnitus ...
Combining sound with tongue stimulation clinically improves tinnitus symptoms in a controlled pivotal trial. Nat. Commun. In Press (2024) ...
Assessment of Bimodal Stimulation Device Compliance ...
It has also been evaluated in two large-scale clinical trials in over 500 tinnitus participants, demonstrating tinnitus benefit and minimal risk with high ...
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