Brain wave test may reveal tinnitus relief

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Treatment Group 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 (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) Treatment Group Exclusion Criteria: * 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. Control Group 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 Control Group Exclusion Criteria: * Began wearing hearing aids within the past 3 months * 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 previously diagnosed with psychosis or schizophrenia * A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered * Prisoner * PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided.