An interventional study of Sham Device and tVNS Device in Tinnitus and Subjective Tinnitus, sponsored by Neurive Co.,Ltd.. Completed at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Neurive Co.,Ltd. · Not applicable, Interventional, and Treatment
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.
This was a prospective, single-center, randomized, double-blind, sham-controlled exploratory clinical trial designed to evaluate the efficacy and safety of Soricle, a Class III medical device combining transcutaneous vagus nerve stimulation (tVNS) and sound stimulation, for the treatment of subjective tinnitus.
Participants diagnosed with subjective tinnitus were randomly assigned in a 1:1 ratio to either the active treatment group or the sham control group. The investigational device was applied daily for 8 weeks.
The primary objective of the study was to evaluate the improvement in tinnitus symptoms, and secondary objectives included additional efficacy assessments and safety evaluations. Safety was monitored throughout the study, including the assessment of adverse events.
The study was conducted in accordance with ICH-GCP guidelines and was approved by the Institutional Review Board. All participants provided written informed consent prior to participation.
412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.
This study's enrollment of 36 is below the median of 60 across 339 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →This is the only study on the registry with Neurive Co.,Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received a sham device identical in appearance to the active device but without delivering therapeutic stimulation.
Device: Sham Device
Participants received transcutaneous vagus nerve stimulation (tVNS) using the investigational device.
Device: tVNS Device
Participants received combined transcutaneous vagus nerve stimulation (tVNS) and sound stimulation using the investigational device.
Device: tVNS + Sound Stimulation Device
A sham device identical in appearance to the active device but without delivering therapeutic stimulation.
A medical device delivering transcutaneous vagus nerve stimulation (tVNS) via auricular stimulation.
A medical device delivering combined transcutaneous vagus nerve stimulation (tVNS) and sound stimulation.
Change in Tinnitus Handicap Inventory (THI) Score
The change in Tinnitus Handicap Inventory (THI) score from baseline to 8 weeks was assessed to evaluate the effectiveness of the intervention.
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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