Intracochlear Injection of Glucocorticoid
Launched by EYE & ENT HOSPITAL OF FUDAN UNIVERSITY · Aug 14, 2025
Trial Information
Current as of November 14, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment for people who suddenly lose hearing in one ear without a clear cause, a condition known as sudden sensorineural hearing loss (SSNHL). The study is testing whether injecting a steroid medicine directly into the inner ear can safely help improve hearing when standard treatments haven’t worked after two weeks. The goal is to see if this approach can be a helpful "rescue" treatment for those with severe hearing loss.
To be eligible, participants need to be between 18 and 65 years old and have experienced a sudden, severe hearing loss in one ear that has not improved after 14 days of usual treatment. People with hearing loss caused by other known conditions, those with hearing loss in both ears, or those with certain medical problems like recent strokes or serious liver or kidney issues would not be able to join. If chosen for the study, participants will receive the steroid injection through a small opening near the ear and will be closely monitored to check for safety and any improvement in hearing. This study is still in the early stages and has not started recruiting patients yet.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age between 18 and 65 years Unilateral idiopathic sudden sensorineural hearing loss greater than 95dB at the average of 4 frequencies (500 Hz, 1000 Hz, 2000 Hz and 4000 Hz) in PTA (contralateral hearing is less than 30dB) at the onset of sudden hearing loss Participant who were treated with standard treatment for 14 days, but no recovery was confirmed as type IV (final hearing level with hearing gain of ≤15 dB) at the end of the 14-day treatment
- Exclusion Criteria:
- • Bilateral sudden sensorineural hearing loss Hearing loss with known causes (e.g., Meniere's disease, retrocochlear pathology, history of otologic surgery, perilymphatic fistula, barotrauma) History in the past 6 months of ototoxic treatment such as chemotherapy, use of loop diuretics, high dose aspirin, etc History of sudden sensorineural hearing loss within the past 2 years History of ischemic diseases (cerebral infarction, myocardial infarction, peripheral arterial obstructive disease) Neuropsychiatric disorders (epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis) Severe hepatic or renal insufficiency The CT diagnosis is "abnormality of the round window niche"
About Eye & Ent Hospital Of Fudan University
The Eye & ENT Hospital of Fudan University is a leading clinical research institution dedicated to advancing the fields of ophthalmology and otolaryngology. With a commitment to innovative medical practices and patient-centered care, the hospital integrates cutting-edge research with clinical expertise to conduct comprehensive clinical trials. Leveraging a multidisciplinary approach, the institution aims to enhance treatment modalities and improve patient outcomes through rigorous scientific investigation and collaboration with academic and industry partners. Its state-of-the-art facilities and experienced team of professionals position the Eye & ENT Hospital of Fudan University as a pivotal contributor to medical advancements in eye and ear, nose, and throat health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
Patients applied
Trial Officials
Yilai Shu, MD, Ph.D
Principal Investigator
Eye & ENT Hospital, Fudan University, Shanghai, China
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported