Development of a Novel Algorithm for Tip Fold-Over Detection in Cochlear Implants and Evaluation on Bench and...

Area of Science:

• Otolaryngology
• Biomedical Engineering
• Medical Device Technology

Background:

• Tip fold-over (TFO) is a rare but critical complication in cochlear implant surgery, potentially impairing device function.
• Early detection of TFO is crucial for timely intervention and optimal electrode array placement.
• Electric field imaging (EFI) shows potential for intraoperative and postoperative TFO identification.

Purpose of the Study:

• To evaluate the performance of a TFO detection algorithm in Advanced Bionics cochlear implant systems.
• To assess the algorithm's sensitivity and specificity using bench and patient data.
• To determine the clinical utility of the TFO algorithm as an intraoperative alert system.

Main Methods:

• Algorithm validation using bench tests with artificial cochleae and human temporal bones.
• Intraoperative EFI data collection with imaging-confirmed electrode placement.
• Analysis of historical EFI data from a large cochlear implant database (DataLake).

Main Results:

• The TFO algorithm demonstrated 100% sensitivity and specificity in bench and intraoperative settings.
• All four intraoperatively confirmed TFOs were correctly identified by the algorithm.
• Analysis of 14,734 implants revealed a 0.80% TFO flag rate, with higher prevalence in pre-curved arrays.

Conclusions:

• The TFO detection algorithm is highly reliable for identifying electrode array issues using clinical EFI data.
• The algorithm serves as a valuable, rapid screening tool for potential TFOs.
• While not a substitute for imaging, the algorithm enhances intraoperative awareness and decision-making.