BACKGROUND: Cochlear implants (CI) are the established treatment for cochlear deafness. Recently, indications for cochlear implantation have been expanded to include severely hearing-impaired patients. The use of bilateral implants seems to provide additional benefit. Moreover, new electrode designs, i. e. perimodiolar electrode arrays, aim at improving benefit for patients. However, in addition to providing functional improvements, modern electrode array development must also address safety aspects, because damage to the cochlear morphology (especially the osseous spiral lamina) may lead to degeneration of residual neuronal structures and bony obliteration or scarring within the cochlear ducts. METHODS: Therefore, insertion trauma of the newly developed electrode arrays in human temporal bones must be evaluated before applied to patients. Several methods for testing electrode location and intracochlear trauma are described. RESULTS: Combining cross-sectional imaging, histological analysis and elements of risk-assessment valid information about trauma and possible consequences for use in patients can be determined, based on our experience in 57 temporal bones. CONCLUSIONS: Following our results, safety studies with prototype electrode arrays should, in addition to radiological examination, always include careful histomorphological evaluation.
BACKGROUND: Cochlear implants (CI) are the established treatment for cochlear deafness. Recently, indications for cochlear implantation have been expanded to include severely hearing-impairedpatients. The use of bilateral implants seems to provide additional benefit. Moreover, new electrode designs, i. e. perimodiolar electrode arrays, aim at improving benefit for patients. However, in addition to providing functional improvements, modern electrode array development must also address safety aspects, because damage to the cochlear morphology (especially the osseous spiral lamina) may lead to degeneration of residual neuronal structures and bony obliteration or scarring within the cochlear ducts. METHODS: Therefore, insertion trauma of the newly developed electrode arrays in human temporal bones must be evaluated before applied to patients. Several methods for testing electrode location and intracochlear trauma are described. RESULTS: Combining cross-sectional imaging, histological analysis and elements of risk-assessment valid information about trauma and possible consequences for use in patients can be determined, based on our experience in 57 temporal bones. CONCLUSIONS: Following our results, safety studies with prototype electrode arrays should, in addition to radiological examination, always include careful histomorphological evaluation.