User's Guide

81NUCLEUS 7 SOUND PROCESSOR USER GUIDE
OTHER INFORMATION
Certification and applied standards
The Nucleus 7 Sound Processor fulfils the essential
requirements listed in Annex 1 of the EC directive 90/385/EEC
on Active Implantable Medical Devices as per the conformity
assessment procedure in Annex 2.
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The year in which authorisation to affix the CE mark was
granted was 2016.
The Nucleus 7 Sound Processor also fulfils the essential
requirements listed in the EC directive 1999/5/EC on Radio
and Terminal Telecommunication Equipment as per the
conformity assessment procedure in Annex IV.
DRAFT ONLY FOR CLINICAL TESTING
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