Abstract

The main objective of this study is to evaluate the short-term and long-term audiological outcomes in patients who underwent cochlear implantation with a robot-assisted system to enable access to the cochlea, and to compare outcomes with a matched control group of patients who underwent cochlear implantation with conventional access to the cochlea. In total, 23 patients were implanted by robot-assisted cochlear implant surgery (RACIS). To evaluate the effectiveness of robotic surgery in terms of audiological outcomes, a statistically balanced control group of conventionally implanted patients was created. Minimal outcome measures (MOM), consisting of pure-tone audiometry, speech understanding in quiet and speech understanding in noise were performed pre-operatively and at 3months, 6months, 12months and 2years post-activation of the audioprocessor. There was no statistically significant difference in pure-tone audiometry, speech perception in quiet and speech perception in noise between robotically implanted and conventionally implanted patients pre-operatively, 3months, 6months, 12months and 2years post-activation. A significant improvement in pure-tone hearing thresholds, speech understanding in quiet and speech understanding in noise with the cochlear implant has been quantified as of the first measurements at 3months and this significant improvement remained stable over a time period of 2years for HEARO implanted patients. Clinical outcomes in robot-assisted cochlear implant surgery are comparable to conventional cochlear implantation. CLINICALTRAILS. NCT03746613 (date of registration: 19/11/2018), NCT04102215 (date of registration: 25/09/2019).

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