Safety and Efficacy of Intratympanic Application of Dexamethasone Via Catheter in Patients With Sudden Hearing Loss

Exclusion Criteria

• •Age is less than 18 or greater than 75 years old
• •Hearing loss occurred less than 12 days or more than 21 days ago
• •Positive pregnancy test, risk of pregnancy (insufficient protection or lactation
• •Middle ear inflammation or effusion
• •Ear canal inflammation
• •Conductive hearing loss of greater than 10 dB
• •Sudden bilateral hearing loss
• •Presence of any conditions or symptoms which indicate that the hearing loss is not ISSNHL, for example, acoustic trauma, Meniere's disease, fluctuating hearing loss, endolymphatic hydrops, suspected retro-cochlear lesion, hearing loss due to ear surgery, perilymph fistula or barotrauma.
• •Pulse synchronic tinnitus (potentially due to glomus jugulare tumor)
• •Previous otologic surgery (excluding ventilation tubes)
• •History in the past 6 months of ototoxic treatment such as chemotherapy, use of loop diuretics, high dose aspirin, etc.
• •Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction
• •Use of non-permitted treatment during the study
• •Intake of experimental drugs or participation in a clinical study within the last 30 days
• •Only hearing ear
• •History of drug abuse or alcoholism
• •History of an ischemic disorder (previous strokes, previous heart attacks, peripheral arterial occlusion disease)
• •Patient is not capable of understanding the informed consent form (whether due to its language or for other reasons)
• •Any psychiatric syndrome requiring treatment with neuroleptics, antidepressants, hypnotics or anxiolytics which has/have been prescribed within three month preceding inclusion into the study and/or cannot be continued at the same dose during the study
• •Any severe (systemic) neurological disease (e.g. Epilepsy, Parkinson's disease, Dementia/Alzheimer's disease, Multiple sclerosis)
• •Any reason, in the investigator's opinion, that prohibits inclusion into the study