This study is a prospective, randomized pilot study. To verify an efficacy/safety of the mixed drug injectable delivery vehicle for treating intractable hearing loss. Hearing test, endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation.
The goal of this clinical trial (pilot study) is to evaluate the Efficacy and Safety of Combined Hyaluronic Acid and Dexamethasone Treatment in Patients with Hearing Loss. The main questions it aims to answer are: • Q1. Verification of safety, • Q2. Therapeutic effect of drug injection on sensorineural hearing loss. Participants will undergo several assessment tests (Verification of adverse effects in the external and middle ear through endoscopy, Confirmation of adverse effects through imaging, Hearing test to check for additional hearing loss, Check if subjective ear fullness persists for more than a week aside from the drug effect). If there is a comparison group: Researchers will compare dexamethasone and hyaluronic acid to verify hearing improvement and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
26
Analysis of Side Effect Rate through tympanic membrane endoscopy Imaging in 26 participants
Confirming healing time of perforation and inflammation (Safety)
Time frame: 0, 1day and 1 week after intratympanic injection
Analysis of Drug Duration through CT Imaging in 26 participants
Checking a time duration of drug in middle and inner ear (Durability)
Time frame: 0, 1day and 1 week after intratympanic injection
Comparison of Auditory Threshold Values Between Two Groups to Confirm Treatment Efficacy in 26 participants
Verifying therapeutic effect of intratympanic drug delivery vehicle (Efficacy)
Time frame: 0, 1day, 1 week and/or 1 month after intratympanic injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.