The research objective of the proposed usability study is to assess the compliance and acceptance/satisfaction of using a bimodal stimulation device with the modification of the sound stimulus to the participant's tinnitus pitch. In particular, the sound stimulus will not contain the pitch of the tinnitus, which may increase comfort and usability with the device since it will be customized to their tinnitus. Furthermore, virtual follow-up assessments and/or phone calls will be performed, thus significantly reducing the burden and personnel requirements for in-person visits as originally performed with the current clinic process.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
The device is a non-invasive stimulation device that consists of a controller that connects to headphones for sound delivery to the ears and connects to a mouth component that provides gentle electrical stimulation to the tongue surface. The sound is currently configured according to a tinnitus person's audiogram (i.e., hearing threshold profile for different sound frequencies) during device fitting. Individuals are recommended to use the device for 60 minutes daily (two 30-minute sessions consecutively or at different times of the day) for at least 12 weeks.
University of Minnesota - PWB
Minneapolis, Minnesota, United States
Compliance rate after 12 weeks of bimodal stimulation
Measure compliance rate in terms of the amount of time using the bimodal stimulation device over a 12 week period and demonstrate a similar rate to previous published results.
Time frame: From enrollment visit to end of bimodal stimulation at 12 weeks
Satisfaction rate after 12 weeks of bimodal stimulation
Measure satisfaction rate in terms of two satisfaction questions after 12 weeks of bimodal stimulation and to demonstrate a similar rate to previous published results.
Time frame: From enrollment visit to end of bimodal stimulation at 12 weeks
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