Efficacy and Safety of the Soricle for Subjective Tinnitus Relief

April 17, 2026 updated by: Neurive Co.,Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea
        • Korea University Guro Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 years or older
  • Patients with subjective tinnitus
  • Able to understand and provide informed consent
  • Willing to comply with study procedures

Exclusion Criteria:

  • Objective tinnitus
  • Severe hearing loss requiring immediate treatment
  • History of neurological or psychiatric disorders that may affect study outcomes
  • Use of other tinnitus treatments during the study period
  • Any condition that, in the investigator's judgment, may interfere with study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Comparator
Participants received a sham device identical in appearance to the active device but without delivering therapeutic stimulation.
Device: Sham Device
A sham device identical in appearance to the active device but without delivering therapeutic stimulation.
Experimental: tVNS Stimulation
Participants received transcutaneous vagus nerve stimulation (tVNS) using the investigational device.
Device: tVNS Device
A medical device delivering transcutaneous vagus nerve stimulation (tVNS) via auricular stimulation.
Experimental: tVNS + Sound Stimulation
Participants received combined transcutaneous vagus nerve stimulation (tVNS) and sound stimulation using the investigational device.
Device: tVNS + Sound Stimulation Device
A medical device delivering combined transcutaneous vagus nerve stimulation (tVNS) and sound stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tinnitus Handicap Inventory (THI) Score
Time Frame: 8 weeks
The change in Tinnitus Handicap Inventory (THI) score from baseline to 8 weeks was assessed to evaluate the effectiveness of the intervention.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurive Co.,Ltd.

Investigators

  • Principal Investigator: Jaegu Cho, Korea University Guro Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Actual)

September 8, 2025

Study Completion (Actual)

September 8, 2025

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEU_SO_03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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