Purpose: 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.
Methods: 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 3 months, 6 months, 12 months and 2 years post-activation of the audioprocessor.
Results: 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, 3 months, 6 months, 12 months and 2 years 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 3 months and this significant improvement remained stable over a time period of 2 years for HEARO implanted patients.
Conclusion: Clinical outcomes in robot-assisted cochlear implant surgery are comparable to conventional cochlear implantation. CLINICALTRAILS.
Gov trail registration numbers: NCT03746613 (date of registration: 19/11/2018), NCT04102215 (date of registration: 25/09/2019).
Keywords: Cochlear implantation; Hearing outcomes; Image-guided surgery; Robot-assisted cochlear implant surgery; Sensorineural hearing loss.
© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.