Overview
The aim of the proposed study is to investigate the use of resting-state Electroencephalogram (EEG)-Based Brain Entropy (EBDBE) and auditory brainstem responses (ABR) as an objective measure of tinnitus improvement following the use of a bimodal stimulation device in individuals with tinnitus after six weeks of bi-modal stimulation.
Eligibility
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.