Preclinical Study of a Minimally Invasive Cochlear Implant Device Based on 3D Printing of a Custom Guide

Area of Science:

• Otolaryngology
• Medical Device Engineering
• Surgical Innovation

Background:

• Cochlear implantation is a vital treatment for severe hearing loss.
• Minimally invasive surgical techniques aim to improve patient outcomes and reduce risks.
• Developing precise surgical guides is crucial for accurate electrode placement.

Purpose of the Study:

• To evaluate the feasibility and precision of a custom 3D-printed guide for minimally invasive cochlear drilling.
• To assess the safety of the 3D-printed guide by measuring proximity to critical anatomical structures.

Main Methods:

• A prospective performance study involving four patients (eight temporal bones) undergoing cochlear implantation.
• A custom 3D-printed drill guide was used to create a minimally invasive cochleostomy.
• Accuracy was measured by comparing the drilled cochleostomy axis to the preoperatively planned ideal axis (target < 0.5 mm).
• Proximity to facial nerve, external auditory meatus, stapes, and chorda tympani was assessed.

Main Results:

• The mean accuracy of the cochleostomy axis was 0.51 ± 0.21 mm, closely approaching the target precision.
• No damage to critical anatomical structures was reported during the procedure.
• The guide demonstrated satisfactory safety margins around vital nerves and structures.

Conclusions:

• The custom 3D-printed guide is a feasible tool for precise, minimally invasive cochleostomy in cochlear implantation.
• The guide offers reassuring safety data, making further development and larger studies warranted.
• Future research should focus on enhanced software, equipment, and assessing electrode insertion quality.