Assessment of Bimodal Stimulation Device Compliance and Satisfaction in Individuals With Tinnitus
Tinnitus
About this trial
This is an interventional device feasibility trial for Tinnitus
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 THI score from 38 to 76
- Hearing loss condition (low hearing loss group (n=10) and high hearing loss group (n=10))
- Access to reliable internet connection and device to complete virtual video visits and electronic surveys
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
- 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 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 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 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 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
- Current or previous involvement in medico-legal cases
- 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.
Sites / Locations
- University of Minnesota - TESSLab/PWB
Arms of the Study
Arm 1
Experimental
Single study arm
The Lenire device is CE marked in Europe and intended to reduce the symptoms of tinnitus. It comprises a handheld controller and an intra-oral device called a Tonguetip® Intra-Oral Device (IOD), which delivers gentle electrical stimulation to the tongue, and also comprises of a set of wireless consumer headphones that deliver audio stimulation. The sound and tongue stimulus parameters such as stimulus rate, stimulus intensity, and the timing relationship between the auditory and somatosensory stimulus events are grouped into stimulation Parameter Sets (PS). PS1 is used during the first 6-weeks of stimulation and PS4 is used during the second 6-weeks of stimulation, similar to what is routinely used for tinnitus individuals in Europe. For this study, the device software has been modified to allow users to adjust the headphone volume to a level that is comfortable and clearly audible instead of a preset volume with limited adjustments based on the patient's audiogram.