Severe Tinnitus
Conditions
Brief summary
This is a proof-of-concept study designed to provide feasibility information on the clinical use of vagus nerve stimulation (VNS) paired with tones for the treatment of severe tinnitus. The study is expected to give preliminary efficacy and safety information.
Interventions
Daily stimulation synchronized with tones at the study assigned dose (amplitude, frequency, on/off cycle and treatment period).
Sponsors
MicroTransponder Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 18 to 65 years of age * Diagnosed with subjective tinnitus due to hearing loss with at least some tonal quality of the tinnitus. * Diagnosis of tinnitus for at least one year * Tinnitus severity of 18 or greater on TRQ cross checked with TQ severity of Grade 3 or worse Key
Exclusion criteria
* Acute or intermittent tinnitus * Severe hearing loss * History of significant ear disease such as Meniere's disease, ear tumors, or evidence of active middle ear disease. * Any other implanted device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Audiometric measurements | weekly through one month |
Secondary
| Measure | Time frame |
|---|---|
| tinnitus questionaires | weekly through one month |
| adverse events | as they occur |
Countries
Belgium
Outcome results
None listed