CompletedNot Applicable

Efficacy and Safety of the Soricle for Subjective Tinnitus Relief

South Korea36 participantsStarted 2025-03-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Tinnitus Handicap Inventory (THI) Score

Timeframe: 8 weeks

Trial details

NCT IDNCT07548320

SponsorNeurive Co.,Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-08

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