RESUMO
OBJECTIVE: Hearing loss occurring in temporal association with the topical application of otic medications is regularly reported to the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit - BVL) in the form of adverse event (AE) reports. Although deafness or impaired hearing are listed as possible adverse reactions in the Summary of Product Characteristics of the otic medications approved in Germany little information about the underlying causes is available to date. MATERIAL AND METHODS: A search for cases reporting impaired hearing following the use of otic medication was conducted in the national AE database. Subsequently, descriptive analysis was performed. Due to their small number, cases involving cats were excluded. Possible risk factors and causes of hearing loss were considered against the background of current literature. RESULTS: While dogs of all age groups were affected, the majority of reports referred to dogs older than 10â years of age. Besides crossbreds, dogs of the breeds West Highland White Terrier, Dalmatian, Miniature Poodle and French Bulldog were most frequently involved. The analysis of the available data does not point to specific products or active substances that could be associated with a more frequent occurrence of hearing loss. CONCLUSION AND CLINICAL RELEVANCE: In addition to possible ototoxicity of a product, other causes of hearing loss should be considered. These include the underlying otitis itself, age-related hearing loss, previously undetected unilateral congenital deafness, or conductive deafness due to obstruction of the ear canal. Treatment options include discontinuation of potentially ototoxic substances or treatment of conductive deafness, e.â g. by removal of drug residues and exudate or treatment of otitis media. In the case of hearing loss subsequent to the use of otic medication, the BVL should be notified of this event in as much detail as possible in order to further improve the data situation concerning this topic.