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09/2 - Impianti cocleari indagine su stato dell’arte, problematiche riscontrate, aspetti clinici e normativi.Daniele Giansanti, Sandra Morelli, Giovanni Maccioni, Mauro Grigioni2009, ii, 51 p.
Cochlear implants: a study on technology, problems found, clinical and regulamentation aspects.
Daniele Giansanti, Sandra Morelli, Giovanni Maccioni, Mauro Grigioni
2009, ii, 51 p. (in Italian)
The Istituto Superiore di Sanità (the National Institute of Health in Italy) has started a preliminary study on the cochlear implant but basic to the future aspects. In this first phase it has been investigated the evolution of the cochlear implants, from the single channel to the multiple. Particular attention has been also devoted to aspects about the optimization of the candidature, the risk analysis, and the performances obtained during the three decades of experience. The study thus faces the possible problems considering the experience of world leaders, such as the American agency for the safety regulation, the Food and Drug Administration (FDA) and other international references. The study ends by means of a little look at the rehabilitation problems of patients with the cochlear implant. The study has first of all the aim to represent a reference tool for the cochlear implant on the technological, regulation and clinical aspects. Finally the study has the aim to represent a meeting point for all the subjects interested in this medical device.
Key words: Cochlea, Cochlear implants, Medical devices
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