Could a Tongue-Zapping device silence ringing ears?
NCT ID NCT07092033
First seen Jun 24, 2026 · Last updated Aug 05, 2026 · Updated 4 times
Summary
This study tests a non-invasive device that delivers sound through headphones and gentle electrical pulses to the tongue, aiming to ease tinnitus. Twenty adults with chronic tinnitus will use the device for 60 minutes daily over 12 weeks. The main goal is to see if people find the device comfortable and easy to use, not necessarily to prove it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bimodal neuromodulation device (sound and tongue stimulation)
- What this could lead to
- If successful, this could lead to a more comfortable, personalized way to manage tinnitus symptoms at home.
- What could go wrong
- This is a small, early-stage usability study with only 20 people, so results may not apply to everyone. The device may not reduce tinnitus for all users.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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19 people
The number who actually took part.
- Started
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Jul 2025
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Minnesota - PWB
Minneapolis, Minnesota, 55455, United States
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Other studies related to the condition(s) this trial covers.
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