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Behavioural Intervention

Bimodal Stimulation Device for Tinnitus

Waitlist Available
Led By Meredith Adams, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjective tinnitus
Tinnitus duration of greater than or equal to 3 months and less than or equal to 20 years at time of consent
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Upenrollment visit to week 12 visit (end of device stimulation) and 12 week follow-up visit
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a device to help with symptoms of chronic subjective tinnitus. The device, called Lenire, is a non-invasive stimulator that is worn in the mouth and delivers electrical stimulation to the tongue surface. It is also worn with headphones that deliver sound to the ears. The device is used for two 30-minute sessions each day, for a total of 60 minutes daily. The objective of the study is to assess compliance and satisfaction with the device, with the hope that it will help a larger population of people who suffer from tinnitus.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have ringing or buzzing in your ears.
You have had tinnitus for at least 3 months but no more than 20 years when you agree to join the study.
Your initial THI score is between 38 and 76.
You have hearing loss.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment visit to week 12 visit (end of device stimulation) and 12 week follow-up visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment visit to week 12 visit (end of device stimulation) and 12 week follow-up visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compliance rate after 12 weeks of bimodal stimulation
Secondary outcome measures
Satisfaction rate after 12 weeks of bimodal stimulation
Other outcome measures
Impact of the stimulation device on anxiety after 12 weeks of bimodal stimulation
Acoustic Stimulation
Acoustic Stimulation
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single study armExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,339 Previous Clinical Trials
1,582,347 Total Patients Enrolled
3 Trials studying Tinnitus
33 Patients Enrolled for Tinnitus
Neuromod Devices LimitedUNKNOWN
Kent TaylorUNKNOWN

Media Library

Lenire bimodal stimulation device (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05518682 — N/A
Tinnitus Research Study Groups: Single study arm
Tinnitus Clinical Trial 2023: Lenire bimodal stimulation device Highlights & Side Effects. Trial Name: NCT05518682 — N/A
Lenire bimodal stimulation device (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05518682 — N/A
Tinnitus Patient Testimony for trial: Trial Name: NCT05518682 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still room for participants in this experiment?

"According to information on clinicaltrials.gov, this research is not currently open for recruitment. It was initially posted on September 19th 2022 and the most recent update occurred November 18th 2022. However, 45 other studies are accepting participants presently."

Answered by AI

Who else is applying?

What state do they live in?
How old are they?
18 - 65
What site did they apply to?
University of Minnesota - TESSLab/PWB
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

TINIITUS IS A BURDEN. Looking for solution for my Tinnitus. I want to do something about the Tinnitus.
PatientReceived 1 prior treatment
I’m interested in helping to find a Tinnitus cure. Im very interested to a treatment that might work.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

When can I start? Can I do this trial from home? How long will the screenings take?
PatientReceived no prior treatments
Is there anything close to Raleigh, NC?
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Most responsive sites:
  1. University of Minnesota - TESSLab/PWB: < 48 hours
~21 spots leftby Nov 2024