Assessment of the ototoxicity of docusate sodium (colace) in a guinea pig animal model.

Docusate sodium (Colace) is an off-label ceruminolytic agent used to soften ear wax and relieve ear canal obstruction. At present, its effect on hearing in the presence of tympanic membrane (TM) perforation is not clear. The present study aimed to assess the safety of ototopic docusate sodium on hearing in the presence of TM perforation. A prospective, randomized, controlled trial in a guinea pig animal model. Ten guinea pigs underwent bilateral myringotomy. In each animal, one ear received docusate sodium, serving as the experimental ear, and the other received normal saline as the control. Auditory brain response (ABR) was performed at baseline and then 1, 7, and 14 days following the application. At day 14 following application, there was no significant change in ABR thresholds at 8, 12, 16, 20, or 25 kHz. In guinea pigs with perforated TMs, docusate sodium does not seem to cause ototoxicity. Future clinical studies are required.