Cochlear implants in children: safety as well as speech and language.

The development of cochlear implants for children at the University of Melbourne and the Bionic Ear Institute, has consisted of a routine of biological and engineering safety followed by evaluation of speech processing strategies on adults before they are undertaken on children. The initial safety studies were to ensure that insertion was atraumatic, the electrical stimulus parameters did not lead to loss of ganglion cells and that the electrode could be inserted without the risk of middle ear infection leading to meningitis. The initial second formant extraction scheme was shown to produce significant open-set speech understanding in adults and was approved by the US Food and Drug Administration (FDA) in 1985. Following this, an international study was undertaken for the FDA on children using a strategy that also included the first formant, and was approved in 1990. Additional advances in speech processing have been evaluated on adults. However, before using one with high rates of stimulation, it was tested for safety on experimental animals. Further advances have been anticipated in particular through the development of a peri-modiolar array, the Nucleus Contour. Prior to its use on adults, it was tested in the human temporal bone and found to lead to minimal trauma. It was evaluated in adults and found to lead to better current localization and lower thresholds. A study was undertaken in children using a spectral maxima scheme at high rates (advanced combination encoder (ACE)) and the Contour array as it had given best results in adults. It was approved as safe and effective for use in children in 2000. Studies were also undertaken to look at plasticity and visual dominance particularly through cognitive studies and the use of the McGurk effect. This demonstrated that deaf children with implants rely heavily on visual information and there is a great need to have unambiguous auditory stimuli to get best results.