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Bimodal Stimulation Device for Tinnitus
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.
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- You have experienced tinnitus for at least 3 months but no more than 20 years when you give your permission to participate.You must be 18 years old or older when giving your agreement to participate.You have ringing in your ears.Your initial THI score is between 38 and 76.Criterion: You have a hearing loss condition.You have access to a reliable internet connection and a device capable of accessing the Internet.You have ringing in your ears that gets louder with your heartbeat.You have a specific, identifiable sound in your ears that can be heard by others.You have a documented ear condition that causes hearing loss or have had surgery on your middle ear.You started using hearing aids in the last 3 months.You have been diagnosed with Meniere's disease or another condition that causes your hearing to go up and down.You have been diagnosed with extreme sensitivity to loud noises or certain sounds.You have experienced hearing things that aren't really there in the past.You have a tumor on the nerves related to hearing or balance.You have been to the hospital or seen a doctor for a head or neck injury in the past year.You are currently using benzodiazepines or sedative medications regularly or as needed.You have a condition that may cause seizures or loss of consciousness, like epilepsy.You have a pacemaker or another implanted device that uses electricity.You have been diagnosed with psychosis or schizophrenia in the past.Your initial THI score is between 38 and 76.You have either mild or severe hearing loss.You have been diagnosed with Burning Mouth Syndrome.You have been diagnosed with a bothersome temporomandibular joint disorder (TMJ).You have participated in a study for tinnitus treatment before, or have had surgery or an implant for tinnitus.You are currently or have been involved in legal cases related to medical issues.You are pregnant, according to what you tell us.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.You experience ringing or buzzing in your ears.You have had ringing in your ears for at least 3 months but no more than 20 years when you agree to join the study.
- Group 1: Single study arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- University of Minnesota - TESSLab/PWB: < 48 hours
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