Implants for surgery – Active implantable medical devices
Part 7: Particular requirements for cochlear and auditory brainstem implant systems
(ISO 14708-7:2019); German version EN ISO 14708-7:2022 Class/Status:
Standard,
valid
Released: 2022-12
VDE Art. No.: 0701212
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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