The aim of this study was to determine the magnitude of the risks associated with cochlear implantation. Results from a pool of thirty clinical studies involving cochlear implantation in over 6300 children were obtained from an internet search. The relevant data were transformed to a common time base (patient time) to allow an evaluation of events following implantation. The main outcome measure was cumulative survival probability for all-cause revision surgery. Over 10 years this was estimated to be 0.71. Thus, at 10 years post-implantation close to 30% of children with unilateral implants will have undergone revision surgery. This figure is considerably greater than that commonly reported for overall revision rates and illustrates the importance of interpreting results with respect to the relevant time frame. When non and low-use is incorporated into the analysis the above figure rises to about 37% of children affected. The findings raise concerns about the information provided to both individuals and regulatory bodies regarding the risks associated with cochlear implantation. The consequences for bilateral implantation are apparent. Our recommendations are i) a full disclosure to parents and children of the true magnitude of the risks and ii) for a body with significant expertise in reliability and systems engineering, and no conflicts of interest, to play a major role in the regulatory management of this service.
Keywords: Complications; Health service; Implanted device; Reliability; Revision surgery.
© The Author(s) 2020.