Device Dossier

Prosthesis, internal, ossicular, total

Device Dossier for Prosthesis, internal, ossicular, total (Prosthesis, internal, ossicular, total, Class IIb, sponsor Kevin Grundy (IBD)). ARTG record,…

Intended purpose

Ossicular replacement prostheses surgically implanted into the middle ear as replacements for the malleus, incus, stapes, or a combination of the three function as a mechanical transformer and transmit sound energy from the tympanic membrane to the oval window of the cochlea.

TGA Public Summary