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. CROS unit An option, and hence not an Classification Regulation (including integral part of the hearing 15. follows the follows microphone and aid. Though an accessory a device device telecoil) Not functional, and therefore hearing not a medical device 16. No No aid Earmould Classification Regulation An earmould is a detachable 17.1 follows the follows part that can affect safety. device device An earmould is a detachable Classification Regulation part that can affect safety. 17.2 Ear mold follows the follows device device An earmould is a detachable Ear dome Classification Regulation part that can affect safety 18. (standard e.g follows the follows dome) device device Earphone Classification Regulation An earphone directly affects 19. (e,g used with follows the follows the output of body worn bodyworn) device device hearing aids. A hearing aid is Eyeglass wearable Exempted (1) Class I (general controls) 20. hearing aid Class I 874.300 device that is from 510k for the air-conduction hearing (EG) intended to compensate ESD aid. The air-conduction
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) Classification follows the device Regulation follows device An option, and hence not an integral part of the hearing aid. Though an accessory 16. hearing aid No No Not functional, and therefore not a medical device 17.1 Earmould Classification follows the device Regulation follows device An earmould is a detachable part that can affect safety. 17.2 Ear mold Classification follows the device Regulation follows device An earmould is a detachable part that can affect safety. 18. Ear dome (standard e.g dome) Classification follows the device Regulation follows device An earmould is a detachable part that can affect safety 19. Earphone (e,g used with bodyworn) Classification follows the device Regulation follows device An earphone directly affects the output of body worn hearing aids. 20. Eyeglass hearing aid (EG) Class I 874.300 A hearing aid is wearable device that is intended to compensate ESD Exempted from 510k (1) Class I (general controls) for the air-conduction hearing aid. The air-conduction
Classification-Document-v14.4.docx