This clinical trial is focused on studying a condition known as Idiopathic Sudden Sensorineural Hearing Loss, which is a rapid loss of hearing that occurs without a known cause. The study is comparing two treatments: a single injection of a medication called AC102 into the middle ear and oral tablets of a steroid called Prednisolone. The purpose of the study is to evaluate how effective, safe, and tolerable these treatments are for patients experiencing sudden hearing loss.
Participants in the study will receive either the AC102 injection or the oral Prednisolone tablets. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments. The study will monitor changes in hearing ability over a period of time, specifically looking at improvements in hearing thresholds, which are the softest sounds a person can hear, and speech recognition, which is the ability to understand spoken words.
The study will take place over several weeks, with participants attending regular visits to assess their hearing progress. The main goal is to see if there is an improvement in hearing from the start of the study to the end, which is approximately 28 days after treatment begins. Additional assessments will be conducted up to 84 days to further evaluate the long-term effects of the treatments. This research aims to provide valuable insights into the best treatment options for those affected by sudden hearing loss.



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