None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : - Procedure before laser treatment
? Before the laser treatment, check the subject's treatment site and disinfect the outer ear thoroughly.
- Laser treatment proced
Sponsors
WONTECH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged = 19 years 2. Unilateral subjective tinnitus symptoms for more than 3 months (If the subject has bilateral tinnitus, subject who has dominant symptom between two ears could be enrolled.) 3. A person with a tinnitogram of at least 4 kHz tinnitus frequency 4. Consent to and willing to discontinue medication for tinnitus (eg, Ginkgo-Biloba, Tanamin, etc.) during this trial 5. Women of childbearing age who are confirmed by negative in pregnancy test and who agree to use the contraceptive device during the study 6. Those who agree not to receive any treatment on the ear during the period of clinical trial participation 7. Those who voluntarily participate in the trial and are willing to follow the protocol 8. Those who have fully understood the written consensus
Exclusion criteria
Exclusion criteria: 1. In the cases that the tinnitus has definite cuase (acoustic neurinoma, cerebral tumor, cerebral vessel malformation, vascular tinnitus, tinnitus induced by muscle contraction) 2. Those with history of conductive hearing loss, perforation of the eardrum, etc. 3. Experiences of ototoxic drugs, those who have had meningitis 4. Those who have ear diseases such as external otitis, ear canal occlusion, otitis media 5. Any person who has had a serious disease in cardiovascular, digestive, respiratory, endocrine, or central nervous system, or a mental illness 6. Anyone who is sensitive to light 7. Women of childbearing age who do not agree to contraception during the study 8. Pregnant women or nursing woman 9. Persons who participated in other clinical trials within 30 days prior to screening 10. Other persons deemed inappropriate to participate in this clinical trial at the discretion of the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tinnitus Handicap Inventory, Tinnitus Functional Index;Pure sound hearing test and draft hearing test, Korean version of the Beck Depression Scale (K-BDI), Condition-Characteristic Anxiety Test (STAI-KYZScale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Sound size of sound in a negative-size equilibrium test during a tinnitus check, Sound size of minimum shield check during tinnitus check;All abnormalities occurred to the clinical trial subjects during the clinical trial period | — |
Countries
Korea, Republic of
Contacts
Public ContactJi Eun Choi
Dankook Univeristy Hospital
Outcome results
None listed