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Efficacy and Safety of the Soricle for Subjective Tinnitus Relief

NCT07548320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

  • Tinnitus
  • Subjective Tinnitus

Interventions

DEVICE

Sham Device

A sham device identical in appearance to the active device but without delivering therapeutic stimulation.

DEVICE

tVNS Device

A medical device delivering transcutaneous vagus nerve stimulation (tVNS) via auricular stimulation.

DEVICE

tVNS + Sound Stimulation Device

A medical device delivering combined transcutaneous vagus nerve stimulation (tVNS) and sound stimulation.

Sponsors & Collaborators

  • Neurive Co.,Ltd.

    lead INDUSTRY

Principal Investigators

  • Jaegu Cho · Korea University Guro Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2025-09-08
Completion
2025-09-08

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07548320 on ClinicalTrials.gov