Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss

The main criteria for inclusion: * Male or female aged at least 18 years old * Patients with unilateral idiopathic sudden sensorineural hearing loss or unilateral/bilateral acute acoustic trauma leading to sudden sensorineural hearing loss. * Patients with sudden hearing loss with onset within 96 hours prior to prior to first study drug intake. * Patients under highly effective contraception The main criteria for exclusion: * Bilateral idiopathic hearing loss * Fluctuating hearing loss * History of asymmetric hearing (\>20 dB difference between ears) to the best knowledge of the patient * Severe hearing loss (\>90 dB) associated with unilateral (ipsilateral) complete vestibular loss. * History of Ménière's disease, autoimmune hearing loss, radiation-induced hearing loss, acoustic neuroma (schwannoma), otosclerosis, suspected perilymph fistula or membrane rupture, suspected retro-cochlear lesion, or barotrauma * Previous SSNHL in the affected ear within the past 6 weeks * Complete loss of peripheral vestibular function on the affected side * Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 6 weeks (except oral corticosteroids) * Any ongoing or planned concomitant medication for the treatment of tinnitus until 6 weeks after administration. * Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics, quinine etc.) at the current time or in the past 6 months or planned in the coming 3 months. * Acute or chronic…