Cover E DIN EN ISO 14708-7 VDE 0750-20-7:2019-01
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E DIN EN ISO 14708-7 VDE 0750-20-7:2019-01

* German Language Version *

Implants for surgery – Active implantable medical devices

Part 7: Particular requirements for cochlear implant systems

(ISO/DIS 14708-7:2018); German and English version prEN ISO 14708-7:2018
Class/Status: Draft, valid
Released: 2019-01   Published: 2018-12-07
VDE Art. No.: 1701412
End of objection deadline: 2019-02-07

Contents

A cochlear implant (CI) system helps to restore the sense of hearing for individuals with severe-to-profound sensorineural hearing loss. For individuals with this type of hearing loss, hearing aids provide little or no benefit.
A CI is the only medical device capable of replacing a sense. It works by bypassing non-functioning parts of the inner ear and providing electrical stimulation directly to nerve fibres in the cochlea. A CI system consists of two parts: an externally worn audio processor, which sits comfortably behind or off the ear, and an internal cochlear implant, which is surgically placed just under the skin.

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