Pilot Clinical Study Using Pre-operative Simulation for Patients Undergoing Cochlear Implant

Hypothesis: Patients undergoing pre-operative CI simulation will have improved outcomes as measured by SL, MD and audiological outcomes.

The goal of this aim is to demonstrate clinical feasibility and to collect preliminary efficacy data for using the pre-operative simulation with active feedback for CI patients. This will be achieved by prospectively using the CI simulation system and evaluating both technical and clinical audiological outcomes.

C.4.1 Pre-operative Simulation: Prior to surgery, a simulation with visualization of cochlear microstructures will be created for each patient, and the surgeon will conduct iterative virtual surgery with active feedback to determine the optimal surgical approach and cochlear implant electrode position. Based on the feedback from the simulation platform, the surgeon will determine the optimal CI electrode and surgical technique using the virtual simulation to plan the actual surgery. Post-implant feedback will be displayed to the surgeon. Once parameters (SL, MD, AID) are optimized, a surgical plan will be recorded and used during the actual surgical procedure. A surgical plan will consist of the implant type, cochleostomy site, and insertion techniques used for optimal placement. This will be added to the patient electronic medical record to be referenced immediately prior to surgery. Additionally, the simulator will save all performances with the optimized performance being made available for review on the simulator at any time (3-dimensional playback).

C.4.2 Clinical Outcomes: Aided speech perception testing in the CI ear will be administered at 6- and 12-months post activation using monosyllabic words (CNC Word test) presented at 60 dB SPL (A-weighted) as well as sentences (AzBio) in quiet and at +10 signal-to-noise ratio. Percent correct will be calculated for each test and will serve as the primary clinical outcomes.

C.4.3 User Evaluation: Simulator evaluation (user interface, usefulness, potential usage in future, and overall satisfactory) and feedback/comments from the surgeon about the simulation platform will continued to be collected pre and post-operatively to provide insight into continued future improvement of the simulation platform.