If the cord can be removed from the hearing aid, and the hearing aid works as intended by the Cord manufacturer, the cord is not an (includes cord 14. - No integral part of the hearing aid. It is between receiver and Bodyworn) therefore defined as an accessory, but is - since it may be used for other purposes - not a medical device. CROS unit Yes An option, a detachable part and MEDDEV (including (if too small hence not an integral part of the 15. I Rule 12 Yes 2.1/1 Apr 94 microphone and CE on hearing aid a 1.2 accompanying telecoil) document) Dummy Not functional, and therefore not a 16. - No hearing aid medical device Earmoulds An earmould is a detachable part that are invasive can affect safety. Custom-made Earmould device earmoulds cannot be CE-marked, but 17.1 No IIa connected to must comply with the MDD, VIII- Rule 5 an active device Earmoulds An earmould is a detachable part that are invasive can affect safety. Goes with II. device Article 1 Part d. 17.2 Earmould 1.1c Yes IIa connected to If size is too small CE to put on Rule 5 an active accompanying doc:s device Earmoulds An earmould is a detachable part that Ear dome are invasive can affect safety 18. (standard e.g Yes IIa Rule 5 devices dome) connected to
14. Cord (includes cord between receiver and Bodyworn) - No If the cord can be removed from the hearing aid, and the hearing aid works as intended by the manufacturer, the cord is not an integral part of the hearing aid. It is therefore defined as an accessory, but is - since it may be used for other purposes - not a medical device. 15. CROS unit (including microphone and a telecoil) I Rule 12 Yes MEDDEV 2.1/1 Apr 94 1.2 Yes (if too small CE on accompanying document) An option, a detachable part and hence not an integral part of the hearing aid 16. Dummy hearing aid - No Not functional, and therefore not a medical device 17.1 Earmould IIa Rule 5 Earmoulds are invasive device connected to an active device No An earmould is a detachable part that can affect safety. Custom-made earmoulds cannot be CE-marked, but must comply with the MDD, VIII- 17.2 Earmould IIa Rule 5 1.1c Earmoulds are invasive device connected to an active device Yes An earmould is a detachable part that can affect safety. Goes with II. Article 1 Part d. If size is too small CE to put on accompanying doc:s 18. Ear dome (standard e.g dome) IIa Rule 5 Earmoulds are invasive devices connected to Yes An earmould is a detachable part that can affect safety
Classification-Document-v14.4.docx