Real-world study of CI632 cochlear implant shows hearing improvement in Chinese patients at 6 months

ObjectivesDespite its established efficacy and safety, and wide international use, there is currently limited experience of the CI632 cochlear implant system (Cochlear™ Nucleus® CI632 Profile™ Plus Implant with Slim Modiolar Electrode) in China. The aim of this study was to evaluate the performance and safety of the CI632 system in a Chinese population and gain insights from surgeons implanting this device in a real-world setting.MethodsThis prospective, real-world observational study enrolled children and adults with bilateral moderate sloping to profound sensorineural hearing loss who were identified as candidates for the CI632 system. Participants traveled to the Bo'ao Lecheng International Medical Tourism pilot area for implant surgery, which was performed by experienced cochlear implant surgeons at the Bo'ao Super Hospital. Participants returned to their home province for activation of the device and follow-up management, performed at clinics located across mainland China. Hearing performance was evaluated pre- and post-operatively (3 and 6 months after activation of the device) using aided 4-frequency pure tone thresholds (PTA4 at 500, 1000, 2000, and 4000 Hz) and age-appropriate functional listening questionnaires. At the time of surgery, cochlear implant surgeons completed a survey that assessed ease of implantation and satisfaction with the CI632.ResultsParticipants (n = 25; 18 males, 7 females) were aged between 2 and 62 years (mean 22.6 years). All participants tested were able to access the speech spectrum for PTA4 (500, 1000, 2000, and 4000 Hz) at 6 months post device activation. Improvements in hearing thresholds were evident at 3 and 6 months post device activation [mean within-subject improvement in PTA4 from best-aided baseline: 30 dB (95% confidence interval 34.5, 25.4) at 6 months]. Hearing function as measured with age-appropriate questionnaires showed mean improvements from baseline at both 3 and 6 months post device activation for both adults and children across all domains assessed. No surgical complications were reported. Six mild ear-related adverse events were reported during follow up, all resolved during the study. Surgeons (n = 4) gave high ratings for the ease and satisfaction of the surgical procedure with the CI632 implant, and all surgeons indicated they would consider using this device in future surgeries.ConclusionThis real-world, observational study demonstrated the safety and hearing performance achieved in children and adults with the CI632 implant system when implemented via a representative cochlear implant-management setting in China (travel to a central location for surgery with device activation and follow up at local clinics in mainland China). Surgeons reported high levels of confidence and satisfaction with device insertion. Improvements in hearing function and audiometric outcomes were demonstrated across a wide age-range of participants at 3 and 6 months post activation.