None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : Before intervention>
? Before the intervention, check the side of intervention and sterilize the external ear.
<
intervention procedures>
? The subject will receive the intervention in a quiet room and will be able to listen to quiet music to mask the laser sound.
? The subject and physician wear the laser protective goggles.
? The p
Procedures and precautions after intervention >
? If no adverse effects have occurred or the appropriate action is taken for the adverse effect after the intervention, the physician educates the subject about the remedial action.
? Laser irradiati
Sponsors
Dankook Univeristy Hospital
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. Averaged hearing thresholds > 15 dB at 3000, 4000, or 6000 Hz 4. Subject who did not take any medication for tinnitus one month before enrollment 5. Consent to and willing to discontinue medication for tinnitus (eg, Ginkgo-Biloba, Tanamin, etc.) during this trial 6. Women of childbearing age who are confirmed by negative in pregnancy test and who agree to use the contraceptive device during the study 7. Those who agree not to receive any treatment on the ear during the period of clinical trial participation 8. Those who voluntarily participate in the trial and are willing to follow the protocol 9. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| numerical rating scale for loduness, duration, annoyance;THI (Tinnitus Handicap Inventory) Questionnaire;tinnitogram (loudness, MML);Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| tinnitogram (pitch) | — |
Countries
Korea, Republic of
Contacts
Public ContactJi Eun
Dankook Univeristy Hospital
Outcome results
None listed