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. The tympanoplasty Sizers are intended to be used temporarily during a total tympanoplasty replacement of the ossicles of the middle ear, to determine the functional length of the needed prosthesis. The tympanoplasty Sizers are single-use surgical instruments for transient use.

TGA Public Summary