Insertion procedure, aftercare, and soft-tissue reaction of the 2.5-mm titanium tube system for a transcutaneous air conduction hearing aid system.
The term transcutaneous air conduction hearing aid system designates a new category of hearing devices established by the U.S Food and Drug Administration in 2002. The only product included in this category is the RetroX device manufactured by Auric Hearing Systems, Rheine, Germany. This device consists of two components: a titanium tube system for sound conduction and a hearing processor. The component implanted in the soft tissue of the outer ear is the titanium tube system, for which the outer diameter of the central part has recently been reduced. Both the implantation tools and the tube system itself have been optimized over the last few years with regard to shape and function, thus effectively reducing the surgery involved to a kind of "functional body piercing" procedure. As a result of this, the time required for implantation has been minimized, as has the duration and severity of postoperative soft-tissue reaction. Complications may be avoided by correct positioning and proper mounting of the tube system in the outer ear, comprehensive patient counseling, and scheduled aftercare. One key objective is to ensure that the soft-tissue channel in which the titanium tube is implanted heals without any inflammatory reaction.
Wesendahl
Theo
T
ENT-Clinic Isselstein-Wesendahl, Rheine, Germany. t.wesendahl@t-online.de
D018795:Device Approval; D004431:Ear, External / Q000601:surgery*; D004867:Equipment Design; D004869:Equipment Safety; D006310:Hearing Aids; D034381:Hearing Loss / Q000601:surgery*; D006801:Humans; D008416:Mastoid / Q000601:surgery; D011182:Postoperative Care; D019736:Prostheses and Implants; D014025:Titanium; D014481:United States; D014486:United States Food and Drug Administration
D014025:Titanium