TinnitusNCT07548320
Efficacy and Safety of the Soricle for Subjective Tinnitus Relief
A study testing tVNS Device and tVNS + Sound Stimulation Device in people with Tinnitus and Subjective Tinnitus, run by Neurive Co.,Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Subjective Tinnitus
- What is being tested?
- tVNS Device and tVNS + Sound Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Mar 2025to 8 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Patients with subjective tinnitus
- Able to understand and provide informed consent
- Willing to comply with study procedures
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tinnitus, Subjective Tinnitus
- Being tested
- Sham Device, tVNS Device, tVNS + Sound Stimulation Device
- Keywords
- tinnitus, vagus nerve stimulation, sound stimulation, auricular stimulation, medical device
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham DeviceDevice
A sham device identical in appearance to the active device but without delivering therapeutic stimulation.
tVNS DeviceDevice
A medical device delivering transcutaneous vagus nerve stimulation (tVNS) via auricular stimulation.
tVNS + Sound Stimulation DeviceDevice
A medical device delivering combined transcutaneous vagus nerve stimulation (tVNS) and sound stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Sham Comparator | Sham comparator | Participants received a sham device identical in appearance to the active device but without delivering therapeutic stimulation. Receives: Device: Sham Device |
| tVNS Stimulation | Experimental | Participants received transcutaneous vagus nerve stimulation (tVNS) using the investigational device. Receives: Device: tVNS Device |
| tVNS + Sound Stimulation | Experimental | Participants received combined transcutaneous vagus nerve stimulation (tVNS) and sound stimulation using the investigational device. Receives: Device: tVNS + Sound Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start10 Mar 2025
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1 ratio to either the active treatment group or the sham control group in a parallel design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurive Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaegu Cho, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548320
- Sponsor's protocol ID
- NEU_SO_03
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07548320
- Acronym / sponsor ID
- NEU_SO_03
- Conditions
- Tinnitus, Subjective Tinnitus
- Keywords
- tinnitus, vagus nerve stimulation, sound stimulation, auricular stimulation, medical device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Neurive Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomized in a 1:1 ratio to either the active treatment group or the sham control group in a parallel design.
| Arm | Type | Receives |
|---|---|---|
| Sham Comparator | Sham comparator | Device: Sham DeviceParticipants received a sham device identical in appearance to the active device but without delivering therapeutic stimulation. |
| tVNS Stimulation | Experimental | Device: tVNS DeviceParticipants received transcutaneous vagus nerve stimulation (tVNS) using the investigational device. |
| tVNS + Sound Stimulation | Experimental | Device: tVNS + Sound Stimulation DeviceParticipants received combined transcutaneous vagus nerve stimulation (tVNS) and sound stimulation using the investigational device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Patients with subjective tinnitus
- Able to understand and provide informed consent
- Willing to comply with study procedures
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham DeviceA sham device identical in appearance to the active device but without delivering therapeutic stimulation. | Device | Sham Comparator |
| tVNS DeviceA medical device delivering transcutaneous vagus nerve stimulation (tVNS) via auricular stimulation. | Device | tVNS Stimulation |
| tVNS + Sound Stimulation DeviceA medical device delivering combined transcutaneous vagus nerve stimulation (tVNS) and sound stimulation. | Device | tVNS + Sound Stimulation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaegu Cho principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tVNS Device and tVNS + Sound Stimulation Device in people with Tinnitus and Subjective Tinnitus, run by Neurive Co.,Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tinnitus Handicap Inventory (THI) Score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.