TinnitusNCT07092033
Assessment of Customized Bimodal Stimulation for Tinnitus
A study testing Bimodal Neuromodulation in people with Tinnitus, run by University of Minnesota at 1 site in United States.
Trial summary
The research objective of the proposed usability study is to assess the compliance and acceptance/satisfaction of using a bimodal stimulation device with the modification of the sound stimulus to the participant's tinnitus pitch. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Bimodal Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2025to 29 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Baseline Tinnitus Handicap Inventory (THI) score from 38 to 100
- Access to reliable internet connection and device to complete virtual video visits and electronic surveys
- Tonal tinnitus that can be matched
Who cannot join
- Subjective tinnitus, where pulsatility is the dominant feature
- Objective tinnitus
- Middle ear pathology in either ear including documented/known conductive hearing loss >= 20 dB at three adjacent frequencies or if a diagnosis of a tympanic membrane perforation or other middle ear pathology has been rendered, if there is an indwelling pressure equalization tube by patient report, or if middle ear surgery has been performed.
- Began wearing hearing aids within the past 3 months
- Hearing loss of greater than 80 dB HL in any test frequency in the set {2k,3k,4k,6k,8k} Hz or greater than 40 dB HL in the set {250,500,1k} Hz either unilaterally or bilaterally
- Health care provider has rendered a diagnosis of Meniere's disease or other disorder with fluctuating hearing loss
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- A diagnosis of hyperacusis, misophonia or hypersensitivity to loud noises has been rendered
- 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. See Appendix 2 for a list of medical treatments.
- 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. See Appendix 2 for a list of medical treatments.
- 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. See Appendix 2 for a list of medical treatments.
- 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 within the previous 3 months 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
- Principal Investigator (PI) does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota - PWB
Minneapolis, Minnesota, 55455
About this study
The research objective of the proposed usability study is to assess the compliance and acceptance/satisfaction of using a bimodal stimulation device with the modification of the sound stimulus to the participant's tinnitus pitch. In particular, the sound stimulus will not contain the pitch of the tinnitus, which may increase comfort and usability with the device since it will be customized to their tinnitus. Furthermore, virtual follow-up assessments and/or phone calls will be performed, thus significantly reducing the burden and personnel requirements for in-person visits as originally performed with the current clinic process.
- Conditions
- Tinnitus
- Being tested
- Bimodal Neuromodulation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimodal NeuromodulationDevice
The device is a non-invasive stimulation device that consists of a controller that connects to headphones for sound delivery to the ears and connects to a mouth component that provides gentle electrical stimulation to the tongue surface. The sound is currently configured according to a tinnitus person's audiogram (i.e., hearing threshold profile for different sound frequencies) during device fitting. Individuals are recommended to use the device for 60 minutes daily (two 30-minute sessions consecutively or at different times of the day) for at least 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Customized Bimodal Stimulation | Experimental | 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. Receives: Device: Bimodal Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rate after 12 weeks of bimodal stimulation
Measure compliance rate in terms of the amount of time using the bimodal stimulation device over a 12 week period and demonstrate a similar rate to previous published results.
Measured: From enrollment visit to end of bimodal stimulation at 12 weeks
Secondary outcomes (1)
Satisfaction rate after 12 weeks of bimodal stimulation
Measure satisfaction rate in terms of two satisfaction questions after 12 weeks of bimodal stimulation and to demonstrate a similar rate to previous published results.
Measured: From enrollment visit to end of bimodal stimulation at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start31 Jul 2025
- Primary completion29 Dec 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Feng, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092033
- Sponsor's protocol ID
- STUDY00024155
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Customized Bimodal Stimulation for Tinnitus
- ClinicalTrials.gov ID
- NCT07092033
- Acronym / sponsor ID
- STUDY00024155
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 29 Dec 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research objective of the proposed usability study is to assess the compliance and acceptance/satisfaction of using a bimodal stimulation device with the modification of the sound stimulus to the participant's tinnitus pitch. In particular, the sound stimulus will not contain the pitch of the tinnitus, which may increase comfort and usability with the device since it will be customized to their tinnitus. Furthermore, virtual follow-up assessments and/or phone calls will be performed, thus significantly reducing the burden and personnel requirements for in-person visits as originally performed with the current clinic process.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Customized Bimodal Stimulation | Experimental | Device: Bimodal NeuromodulationThe 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (25 listed)
- Subjective tinnitus, where pulsatility is the dominant feature
- Objective tinnitus
- Middle ear pathology in either ear including documented/known conductive hearing loss >= 20 dB at three adjacent frequencies or if a diagnosis of a tympanic membrane perforation or other middle ear pathology has been rendered, if there is an indwelling pressure equalization tube by patient report, or if middle ear surgery has been performed.
- Began wearing hearing aids within the past 3 months
- Hearing loss of greater than 80 dB HL in any test frequency in the set {2k,3k,4k,6k,8k} Hz or greater than 40 dB HL in the set {250,500,1k} Hz either unilaterally or bilaterally
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bimodal NeuromodulationThe device is a non-invasive stimulation device that consists of a controller that connects to headphones for sound delivery to the ears and connects to a mouth component that provides gentle electrical stimulation to the tongue surface. The sound is currently configured according to a tinnitus person's audiogram (i.e., hearing threshold profile for different sound frequencies) during device fitting. Individuals are recommended to use the device for 60 minutes daily (two 30-minute sessions consecutively or at different times of the day) for at least 12 weeks. | Device | Customized Bimodal Stimulation |
Primary outcome
Compliance rate after 12 weeks of bimodal stimulation
Time frame: From enrollment visit to end of bimodal stimulation at 12 weeks
Measure compliance rate in terms of the amount of time using the bimodal stimulation device over a 12 week period and demonstrate a similar rate to previous published results.
1 secondary outcome
Satisfaction rate after 12 weeks of bimodal stimulation
Time frame: From enrollment visit to end of bimodal stimulation at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Feng principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bimodal Neuromodulation in people with Tinnitus, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance rate after 12 weeks of bimodal stimulation (time frame: From enrollment visit to end of bimodal stimulation at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.