Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation

This study is looking into how a device called Lenire might help people with chronic tinnitus (ringing in the ears). The Lenire device uses headphones to deliver sound and a mouthpiece to give mild electrical stimulation to the tongue. Researchers want to see if changes in your brain waves, measured by an electroencephalogram (EEG), can show how much your tinnitus improves after using the device for six weeks. You can join if you are 18 or older, can read English, and have had tinnitus for at least 3 months but no more than 20 years. The study is currently unclear on its recruitment status and plans to enroll 10 participants.

Study design: This is an interventional study with a planned enrollment of 10 participants. The phase of the study is not specified.
What's involved: You would commit to the full duration of the investigation, which includes using the bimodal stimulation device for six weeks and having your brain waves measured at Week 6.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint for measuring changes in brain waves is at 6 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation

Active, Not Recruiting

NAAges 18+InterventionalTreatment

University of Minnesota

~10 participants

Updated 2026-07-20 on ClinicalTrials.gov

What's tested:Lenire Device

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in brain waves at 6 weeks

Measured over Week 6

Conditions

Tinnitus

Where it's being run

1 sites across 1 states

Minnesota1

Study leadership

Peggy Nelson · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

18 years and over at time of consent

Ability to read and understand English

Willing and able to provide and understand informed consent

Willing to commit to the full duration of the investigation

Subjective tinnitus

Tinnitus duration of greater than or equal to 3 months and less than or equal to 20 years at time of consent (only for participants in treatment group)

Baseline THI score from 40 to 76 (only for participants in treatment group)

Hearing loss condition - can hear the acoustic stimulation of the Lenire device (only for participants in treatment group)

18 years and over at time of consent

Ability to read and understand English

Willing and able to provide and understand informed consent

Willing to commit to the full duration of the investigation

Exclusion

Subjective tinnitus, where pulsatility is the dominant feature (only for participants in treatment group)

Objective tinnitus

Can't hear acoustic stimulation of the Lenire device within its mid- range volume setting

Began wearing hearing aids within the past 3 months

A healthcare provider has diagnosed Meniere's disease or another disorder associated with fluctuating hearing loss.

History of auditory hallucinations

Tumor on the hearing or balance nervous systems

Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months

Initiated new prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.

Ceased prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.

Changed dosage of prescription medications in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.

Any use of benzodiazepines or sedative hypnotics (either regularly or on demand)

Neurological condition that may lead to seizures or loss of consciousness (e.g., epilepsy)

Participant with a pacemaker or other electro-active implanted device

Participant previously diagnosed with psychosis or schizophrenia

Participants diagnosed with Burning Mouth Syndrome

A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered

Previous involvement in a clinical investigation for tinnitus treatment or had an implantable or surgical intervention for tinnitus

Inability to physically or comprehensively use the device

Oral piercings that cannot or will not be removed

Pregnancy per patient report

Prisoner

PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided.