Assessing the manufacturable 32-channel cochlear electrode array: evaluation results for clinical trials.

Area of Science:

• Biomedical Engineering
• Materials Science
• Otolaryngology

Background:

• Cochlear implants require reliable electrode arrays for effective hearing restoration.
• Existing manufacturing methods may limit scalability and precision.
• Development of advanced electrode arrays is crucial for improving cochlear implant performance.

Purpose of the Study:

• To report reliability evaluation results of a newly manufactured 32-channel cochlear electrode array.
• To verify the manufacturability and performance of the electrode array according to international standards.
• To assess the insertion trauma associated with the electrode array in human temporal bone studies.

Main Methods:

• Automated laser micro-machining and layer-by-layer silicone deposition for electrode array fabrication.
• Testing according to ISO Standard 14708-7, including elongation, insulation, flexural, and fatigue tests.
• Human temporal bone studies involving insertion via the round window and histological assessment.

Main Results:

• The electrode array met ISO 14708-7 requirements, maintaining electrical continuity and insulation post-testing.
• Impedance measurements remained above the 100 kΩ pass/fail criterion after saline soaking.
• Human temporal bone studies showed an atraumatic insertion rate of 60.3% (grade 0 or 1) with an average insertion angle of 399.7°.

Conclusions:

• The developed 32-channel cochlear electrode array demonstrates verified reliability in mechanical, electrical, and histological aspects.
• The manufacturing methods enable fine patterning and mass production, suitable for clinical application.
• Further evaluation in clinical trials is planned to assess the performance and stability of the 32-channel cochlear implant system.