Evaluation of the OtoBand as a Treatment to Reduce the Perceived Loudness of Tinnitus
Tinnitus
About this trial
This is an interventional prevention trial for Tinnitus
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects age 18 to 70 years old
- Tinnitus that has been present for at least 90 days
- Tinnitus that is constant or predictable
- Computer and access to internet for online video conference
- Score greater than or equal to 36 on the Tinnitus Handicap Questionnaire
- Access to a PayPal, Venmo account to receive compensation
Exclusion Criteria:
- Tinnitus that first presented within the last 90 days
- Tinnitus Handicap Questionnaire of 29 or less
- Skull base surgery within the last 90 days
- Any skull implant (cochlear implant, bone conduction implant, DBS)
- No history of vitreous detachment in the last 60 days (no new floaters or unexplained flashes of light in the eye)
- Taking benzodiazepines (e.g. clonazepam, lorazepam, diazepam) Participant reports that their tinnitus is caused by a medication they are taking
Sites / Locations
- OtolithLabs https://otolithlabs.com/tinnitustelehealthstudy/
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Otoband efficacy on Tinnitus
Placebo device efficacy on Tinnitus
Participants will wear the Otoband on the flat part of the right mastoid bone, about an inch behind the pinna and level with the ear canal. Each participant will select his/her preferred stimulation level. The OtoBand will be programmed to operate at one of three power levels that are thought to be effective. The OtoBand will record what power level is selected and how long it was operating at that power level as well as the date and time a usage started. The "use log" will be downloaded at Otolith's lab once the device is received. The participant will wear the device for 30 minutes and record their Tinnitus level in a Google Form.
The placebo device will use the same case, headband and battery as the OtoBand. The transducer in the OtoBand will be rotated 90 degrees, so that the placebo device will vibrate in a direction ineffectual at providing bone conducted vibrations. The vibrations will be in the horizontal plane, parallel to the skull, and will not have their energy penetrating the skull all the way to the vestibular system. Each participant will select his/her preferred stimulation level. The placebo devices will be made to vibrate at one of three power levels, none of which are thought to be effective. The placebo will record what power level is selected and how long it was operating at that power level as well as the date and time a usage started. The "use log" will be downloaded at Otolith's lab once the device is received. The participant will wear the device for 30 minutes and record their Tinnitus level in a Google Form.