In search of missing links in otology. II. development of an implantable middle ear drug delivery system: Initial studies of sustained ampicillin release for the treatment of otitis media

The development of a new device that consists of a biodegradable support incorporating a therapeutically releasable amount of ampicillin is presented. This device is in an insertable shape that allows placement into the middle ear via a myringotomy incision. Once in the middle ear cavity, it expands, contacts the walls, and provides extended release of ampicillin. In vitro studies (3 months) documented the consistent release of therapeutic levels of ampicillin. In vivo efficacy was demonstrated in otitis-induced chinchillas (bacterial inoculation). The device compared favorably with topical and systemic treatment and prophylaxis of otitis media. The device was also efficient in repeated bacterial challenges. Topical extended middle ear drug delivery can become a significant form of treatment for middle ear disease, and has the potential of being useful as a source for inner ear drug delivery.