Safety of ofloxacin otic and other ototopical treatments in animal models and in humans.

To assess the safety of topical agents in the middle ear, animal studies were reviewed. Compared with aminoglycoside-containing preparations, which caused significant loss of hair cells in the basal turn of the cochlea, ofloxacin caused no loss of hair cells, even at concentrations higher than used clinically. Moreover auditory brainstem testing revealed no change in auditory thresholds in the ofloxacin-treated animals, whereas neomycin-treated animals showed substantial threshold shifts. In human studies, use of topical ofloxacin 0.3% was not associated with any change in hearing. Topical ofloxacin has no demonstrable adverse effects on middle ear or cochlear function.