Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss

Inclusion Criteria: * Patients with unilateral acute sensorineural hearing loss (ASNHL) with onset 48 hours or less ago * Mean earing loss compared with the unaffected contralateral ear of at least 30 dB in the 3 most affected contiguous frequencies * Age ≥ 18 years and ≤ 60 years * Negative pregnancy test for women of childbearing potential * Able to attend the on-study visits * Written informed consent before participation in the study Exclusion Criteria: * Bilateral ASNHL, if not resulting from acoustic trauma * Suspected perilymph fistula or membrane rupture * Barotrauma * Average air bone gap higher than 20 dB in 3 contiguous frequencies * History of Meniere disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops, suspected retro-cochlear lesion or fluctuating hearing loss * Previous ASNHL incident within the past 6 weeks * Evidence of acute or chronic otitis media or otitis externa on examination * Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 2 weeks * Any ongoing or planned concomitant medication for the treatment of tinnitus until 30 days after administration * Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics, quinine etc.) in the past 6 months prior to study inclusion * History of drug abuse or alcoholism * Any clinically relevant respiratory, cardiovascular, neurological (except vertigo or tinnitus), or psychiatric disorders * Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction * Women who are breast-feeding, pregnant or who plan a pregnancy during the trial * Women of childbearing potential who declare being unwilling or unable to practice contraception such as combined oral contraceptives, injectables, hormonal intra-uterine devices, vasectomised partner or sexual abstinence * Concurrent participation in another clinical trial or participation in another clinical trial within 30 days prior to study entry * Any current anticoagulant therapy (e.g. Aspirin, Marcumar, etc)