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Efficacy and Safety of the Soricle for Subjective Tinnitus Relief
Sponsor: Neurive Co.,Ltd.
Summary
This study was conducted to evaluate the efficacy and safety of Soricle, a medical device combining transcutaneous vagus nerve stimulation and sound stimulation, in patients with subjective tinnitus. Participants were randomly assigned to either the active treatment group or a sham control group in a double-blind manner. The device was used daily for 8 weeks. The primary objective was to assess the improvement in tinnitus symptoms, and safety was evaluated throughout the study period.
Official title: Efficacy and Safety of the Soricle, a Class III Combination Device of Vagus Nerve Stimulation and Sound Stimulation, for Subjective Tinnitus Relief: A Prospective, Single-Center, Randomized, Double-Blind, Sham-Controlled, Exploratory Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2025-03-10
Completion Date
2025-09-08
Last Updated
2026-04-23
Healthy Volunteers
No
Conditions
Interventions
Sham Device
A sham device identical in appearance to the active device but without delivering therapeutic stimulation.
tVNS Device
A medical device delivering transcutaneous vagus nerve stimulation (tVNS) via auricular stimulation.
tVNS + Sound Stimulation Device
A medical device delivering combined transcutaneous vagus nerve stimulation (tVNS) and sound stimulation.
Locations (1)
Korea University Guro Hospital
Seoul, South Korea