The purpose of this study is to compare two methods of cochlear implantation : conventional manual insertion versus robot-assisted in order to verify whether robotic insertion provides better performance in the noisy environment.
To do this, we will compare the two methods of insertion of the electrode holder, on 140 patients candidates for cochlear implantation randomized in two groups (70 conventional surgery versus 70 robot-assisted surgery). All patients will be recruited during 17 months, in our Ear, nose and throat (ENT) Department of the Pitié-Salpêtrière hospital group, the first center for adult patients established in France (on average 180 patients/year).
Patient will be followed for 9 months with clinical evaluation, imaging, audiometric, listening effort and quality of life assessments. These evaluations will be carried out preoperatively and postoperatively at 3 months and 6 months post-activation of the cochlear implant.
Adult patient ≥ 18 years old
Patients with an indication for uni or bilateral, simultaneous or sequential cochlear implantation: severe to profound bilateral deafness with intelligibility ≤70% for Fournier dissyllabic words, in free field, at 60dB with adapted hearing aids.
Patient able to understand the information note and give written consent
Affiliation to a French social security system
Patient who does not speak French
Etiologies of deafness known to be of bad prognosis (auditory neuropathy, congenital profound deafness, immediate post-meningitis profound deafness, vestibular schwannoma on the side of the ear to be implanted)
Impossibility of testing the effect of the cochlear implant alone on hearing results (cochlear implantation in the context of unilateral deafness or fluctuating deafness)
Cochlear implantation requiring the use of a perimodiolar electrode holder.
Parallel
Surgery with RobOtol®
Procedure/SurgeryPatient having cochlear implantation surgery with RobOtol®.
Conventional manual surgery
Procedure/SurgeryPatient having conventional manual cochlear implantation surgery
Auditory performance in noise with the cochlear implant
Evolution of the intelligibility score (Variation of the percentage of words understood) for monosyllabic Lafon words presented at 60 dB SPL with a signal-to-noise ratio of 10 dB (SNR10) between the preoperative score and the score at 6 months post-implantation
Hearing performance in noise after robotic cochlear implantation compared to conventional manual cochlear implantation for phonemes
Evolution of the intelligibility score (Variation of the percentage of words and phonemes understood) for monosyllabic Lafon words presented at 60 dB SPL with a signal-to-noise ratio of 10 dB (SNR10) between the preoperative score and the score at 3 months and at 6 months post-implantation.
Hearing performance in noise under ecological conditions after robotic cochlear implantation compared to conventional manual cochlear implantation
Evolution of the intelligibility score (Variation of the percentage of words understood) for Fr-Bio words presented at 60 dB SPL with a signal-to-noise ratio of 10 dB (SNR10) between the preoperative score and the score at 3 months and at 6 months post-implantation. The noise will be an ecological noise (restaurant or street noise) using the Immersion® system.
Hearing performance in silence after robotic cochlear implantation compared to conventional manual cochlear implantation for words
Evolution of the intelligibility score (Variation of the percentage of words understood) for monosyllabic Lafon words presented at 60 dB SPL in quiet between the preoperative score and the score at 3 months and at 6 months post-implantation.
Hearing performance in silence after robotic cochlear implantation compared to conventional manual cochlear implantation for phonemes
Evolution of the intelligibility score (Variation of the percentage of phonemes understood) for monosyllabic Lafon words presented at 60 dB SPL in quiet between the preoperative score and the score at 3 months and at 6 months post-implantation.
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