Efficacy and Safety of AC102 Compared to Steroids in Adults with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)

Inclusion Criteria:

• Male or female patients aged between 18 and 85 years

• Unilateral ISSNHL

• Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization

• An absolute air conduction hearing threshold of at least 65 dB,

• Patients with a relative hearing loss of at least 30 dB compared to the currentaudiogram of the non-affected ear

Exclusion Criteria:

• Insufficient handling of the language used in the speech audiometry tests

• Bilateral hearing loss

• Acute hearing loss from noise trauma, barotrauma or head trauma in either ear at anytime

• Congenital hearing loss

• Conductive hearing loss or combined hearing loss determined by a 4PTA > 10 dB

• History of ISSNHL in the past 1 years in the affected ear