Study of Application of Transcutaneous Trigeminal Nerve Stimulation and Sound Fusion Stimulation on Tinnitus

Exploring the Effects of Transcutaneous Trigeminal Nerve Stimulation Using NUEYNE-T30 and NUEYNE-T100 and Sound Fusion Stimulation on Tinnitus: A Single-center, Double Blind, Placebo-controlled Group, Investigator Initiated Study (IIT) Study

This study aims to evaluate the efficacy of applying transcutaneous trigeminal nerve stimulation (NUEYNE-T30, NUEYNE-T100) and sound fusion stimulation on tinnitus.

Duration of study period (per participant): Screening period (-7~0 days), Intervention period (30 days) Patient needs to visit site at least 3 times (Screening, V1, V2). V1 can be done with screening visit. Tele-visit should be done on day 15.

Inclusion Criteria:

• adults suffering from tinnitus
• Participants must be 19 to 70 years of age, at the time of screening
• Patient who suffers from tinnitus symptom more than 3 months and scores more than 18(criteria of mild) in Tinnitus Handicap Inventory (THI) examination
• Patients with a hearing threshold of 70dB or less when calculated using the quadrant method in the pure tone audiometry
• A person who has no physical or mental restrictions in participating in clinical trial
• Those who voluntarily agreed to participate in clinical trials
• A person who has no pregnancy plan and has agreed to the contraceptive plan for infertile women during the intervention period of clinical trial

Exclusion Criteria:

• A person who does not meet the inclusion criteria
• A person who has difficulty communicating and conducting examinations.
• The disease of the outer or middle ear or central nervous system.
• Subjects who have difficulty conducting clinical trials due to intellectual or cognitive impairment
• Pregnant or lactating women
• A person who cannot understand or read ICF (illiterate or foreigner)
• A person who received tinnitus treatment (blood circulation enhancer, tranquilizer, tinnitus masker, biofeedback etc.) within 2 weeks of baseline or plans to receive it.
• A person who is difficult to participate in a clinical trial according to the researcher's judgment. (e.g., heart-related problems, seizure, epilepsy. Patients transplanted metal or electronic device in head & neck. Patient suffering from unknown pain. Patients who are warned not to use out clinical trial device or is prohibited from using it.)