Efficacy and Safety of the Soricle for Subjective Tinnitus Relief

Neurive Co.,Ltd.

Status: Completed

Conditions: Subjective Tinnitus; Tinnitus

Treatments: Device: Sham Device; Device: tVNS + Sound Stimulation Device; Device: tVNS Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT07548320

NEU_SO_03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups

Sham Comparator

Sham Comparator group

Description:

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

Treatment:

Device: Sham Device

tVNS Stimulation

Experimental group

Description:

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

Treatment:

Device: tVNS Device

tVNS + Sound Stimulation

Experimental group

Description:

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

Treatment:

Device: tVNS + Sound Stimulation Device