Abstract
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.
Highlights
Many thousands of children have undergone cochlear implant surgery worldwide with bilateral implants being increasingly prescribed in more recent years
In order to obtain a wider body of evidence, we describe in this paper how results gleaned from a pool of clinical studies were transformed to a common time base to allow a better evaluation of events following cochlear implantation and a better evaluation of reliability
Cochlear implantation is described in the literature as a safe and reliable intervention for severe-to-profound bilateral sensorineural hearing loss
Summary
Many thousands of children have undergone cochlear implant surgery worldwide with bilateral implants being increasingly prescribed in more recent years. Regarding cochlear implant revision surgery, published papers contain information on both overall incidence rates and surgical details but time relevant information is, in the main, limited. Efforts have been made to improve reporting standards, comparing results from different studies and sources is difficult and considered by some to be an almost impossible task [5, 6]. This is disconcerting because it indicates an inability to determine reliability with confidence, whether of the implant alone or of the intervention as a whole. The effect of implant recalls because of high failure rates is not well represented. The recall of an implant by Advanced Bionics in 2010 was not represented since the authors report only using one device from this
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