Efficacy and Safety of the Soricle for Subjective Tinnitus Relief

NCT07548320 | Completed

• 1 other identifier: NEU_SO_03
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

tinnitus; vagus nerve stimulation; sound stimulation; auricular stimulation; medical device

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Study Arms (3)

Sham Comparator

SHAM COMPARATOR

Participants received a sham device identical in appearance to the active device but without delivering therapeutic stimulation.

Device: Sham Device

tVNS Stimulation

EXPERIMENTAL

Participants received transcutaneous vagus nerve stimulation (tVNS) using the investigational device.

Device: tVNS Device

tVNS + Sound Stimulation

EXPERIMENTAL

Participants received combined transcutaneous vagus nerve stimulation (tVNS) and sound stimulation using the investigational device.

Device: tVNS + Sound Stimulation Device

Interventions

Sham Device DEVICE

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

Sham Comparator

tVNS Device DEVICE

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

tVNS Stimulation

tVNS + Sound Stimulation Device DEVICE

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

tVNS + Sound Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurive Co.,Ltd.: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaegu Cho

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study was conducted in a double-blind manner. Participants, investigators, care providers, and outcome assessors were blinded to group assignments. The active device and sham device were identical in appearance to maintain blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants were randomized in a 1:1 ratio to either the active treatment group or the sham control group in a parallel design.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: March 10, 2025
• Primary Completion: September 8, 2025
• Study Completion: September 8, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)