“Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts”
Prospectively analyze the use of 3D subtraction CAD/CAM in the operating room environment. Study participants, requiring middle ear surgery and ossicular reconstruction, will be implanted with one of two middle ear implants. The rationale is to complete a pilot study of the technology with a small number of designs. Each implant will be commonly used, in the public domain, and recreated by the CAD/CAM software.
Device - 3D CAD/CAM autograft prosthesis
Surgical ossicular reconstruction with the experimental autograft prosthesis created using 3D subtraction CAD/CAM.
Device - Control device
Surgical ossicular reconstruction with the standard available middle ear prosthesis.
Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts