The research objective of the proposed usability study is to assess the compliance and acceptance/satisfaction of using a bimodal stimulation device with the ability to self-adjust the sound stimulus presented to the ears via headphones. In particular, the CE marked bimodal stimulation portable device, Lenire, which is developed by Neuromod Devices Limited (Dublin, Ireland) to alleviate the symptoms of chronic subjective tinnitus, is currently configured according to a tinnitus person's audiogram (i.e., hearing threshold profile for different sound frequencies) during fitting in a hearing center. Lenire 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. 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 10 weeks. Lenire is already commercialized across Europe and available by audiologists or hearing technicians in numerous hearing centers for treating tinnitus. It has also been evaluated in two large-scale clinical trials in over 500 tinnitus participants, demonstrating tinnitus benefit and minimal risk with high compliance and satisfaction rates. The primary objective of the proposed usability study is to first assess compliance and satisfaction with the Lenire device that does not require an audiogram for fitting and that can be implemented mostly through virtual visits (except for the first visit). These modifications to the Lenire fitting process will reduce the time and personnel effort required for its implementation, enabling a broader patient population to access bimodal stimulation for tinnitus treatment, including military personnel and those who are not nearby hearing centers for in-person sessions. High compliance and satisfaction rates from this small proof-of concept usability study will then justify and guide a larger clinical study to assess efficacy and performance of this newly implemented Lenire device process.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
26
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.
University of Minnesota - TESSLab/PWB
Minneapolis, Minnesota, United States
Compliance rate after 12 weeks of bimodal stimulation
Compliance rate after 12 weeks of bimodal stimulation with minimum compliance of a total of 36 hours
Time frame: Enrollment visit to week 12 visit (end of device stimulation)
Satisfaction rate after 12 weeks of bimodal stimulation
Satisfaction rate (two satisfaction questions) after 12 weeks of bimodal stimulation
Time frame: Enrollment visit to week 12 visit (end of device stimulation)
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