Device Dossier

Surgical procedure kit, ENT, single-use, non-medicated

Device Dossier for Surgical procedure kit, ENT, single-use, non-medicated (Surgical procedure kit, ENT, single-use, non-medicated, Class IIa, sponsor…

Intended purpose

The Insertion Electrode (IE) variants are intended for intra-operative assessment of the condition of the cochlea during inner-ear surgery. They can help the surgeon in establishing whether the cochlear lumen is obstructed or if it is freely accessible up to different insertion depths depending upon the considered electrode variant planned for the implantation.

TGA Public Summary