Impedance and Functional Outcomes in Robotic-Assisted or Manual Cochlear Implantation: A Comparative Study.

Abstract

Introduction: Preservation of residual hearing, mainly the low frequencies, is the current main objective of cochlear implantation. New electrode arrays and the development of minimally invasive surgery have allowed electroacoustic stimulation. Over the past several years, robotic-assisted cochlear implant surgery aimed to improve the insertion process while respecting inner ear structures. However, the introduction of a foreign body inside the cochlea can lead to the development of fibrous tissue around the electrode array, or even induce osteogenesis. These histological changes disrupt the parameters of the cochlear implant, resulting in elevated impedance. In addition, long-term auditory performance can be affected, with a deterioration in word comprehension. We evaluated the potential impact of RobOtol® on impedance changes over time, leading to potentially positive functional outcomes.

Methods: Cochlear implant surgery with a round window approach was performed under general anesthesia. Fifteen Med-El Flex24 electrode arrays were inserted manually and 24 using RobOtol®. All subjects underwent pure-tone audiometry tests before the surgery and at regular intervals up to 1 year after the surgery. Based on the pure-tone average at the low frequencies from 250 to 1,000 Hz, we divided the patients according to the degree of auditory preservation (full preservation ≤15 dB, partial preservation 15 dB-30 dB, significant loss >30 dB). These different groups were compared in terms of impedance changes and auditory performance, specifically word recognition score.

Results: We found proportionally fewer patients who experienced significant low-frequency hearing loss after robotic insertion (53.33% in the manual group compared to 41.67% in the robot-assisted insertion group). Impedance changes at the apex of the electrode array, especially at the first electrode (p = 0.04), after robotic surgery, with less overall variability, a continuous decreasing trend without secondary elevation, and lower values in cases of complete residual hearing preservation (for the three first electrodes: p = 0.017, p = 0.04, p = 0.045). The speech intelligibility amelioration over time showed favorable evolution in patients with complete residual hearing preservation regardless of the insertion method. However, in the absence of auditory preservation, the positive evolution continued more than 6 months after robotic surgery but stagnated after manual insertion (difference at 1 year, p = 0.038; median auditory capacity index 83% vs. 57%).

Conclusion: Atraumatic electrode array insertion with consistent, slow speed and the assistance of RobOtol® minimizes disturbances in the delicate neurosensory structures of the inner ear and leads to better auditory performance.