Efficacy and safety of AM-101 in the treatment of acute inner ear tinnitus--a double-blind, randomized, placebo-controlled phase II study.

Objective: To evaluate the efficacy and safety of intratympanic AM-101 in patients with persistent acute inner ear tinnitus after acute acoustic trauma, idiopathic sudden sensorineural hearing loss (ISSNHL), or acute otitis media.

Study Design: Prospective, double-blind, randomized, placebo-controlled study with follow-up visits on Days 7, 30, and 90.

Setting: Twenty-eight European sites (academic tertiary referral centers and private ENT practices).