Assessment of Customized Bimodal Stimulation for Tinnitus

Launched by UNIVERSITY OF MINNESOTA · Jul 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device designed to help people with tinnitus, which is the experience of hearing ringing or buzzing sounds that aren’t really there. The device uses a special type of sound therapy that is customized so it doesn’t include the exact pitch of your tinnitus. This unique approach may make the treatment more comfortable and easier to use. The study also offers virtual follow-up visits by video or phone, so participants don’t need to come into the clinic as often, making it more convenient.

Adults who have had tinnitus for at least three months but less than 20 years, and who experience a steady ringing or tonal sound, may be eligible to join. Participants need to be able to understand and agree to the study, have a certain level of tinnitus severity, and have access to the internet for virtual visits. The study excludes people with certain ear problems, very severe hearing loss, or other health conditions that could affect the results. If you join, you will use the device and provide feedback on how comfortable and easy it is to use, helping researchers understand if this personalized sound therapy could be a helpful option for people with tinnitus.

Gender

ALL

Eligibility criteria

• 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.