Device Dossier

Prosthesis, internal, ossicular, total

Device Dossier for Prosthesis, internal, ossicular, total (Prosthesis, internal, ossicular, total, Class IIb, sponsor MED-EL Implant Systems). ARTG…

Intended purpose

A tympanoplasty prosthesis intended to be used as a total replacement of the ossicles of the middle ear to restore the mechanical sound transmission from the tympanic membrane to the oval window. The tympanoplasty prosthesis is intended to treat patients of all ages.

TGA Public Summary