Assessment of Customized Bimodal Stimulation for Tinnitus

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.