an active device An earphone directly affects the Earphone Earphone is output of body worn hearing aids, and 19. (e,g used with IIa an active Yes is therefore classified as IIa. It is also bodyworn) device sold separate from the hearing aid, Rule 9 and must therefore be CE-marked Eyeglass Eyeglass hearing aids are classified as EG is an 20. hearing aid IIa Yes IIa Rule 9 active device (EG) Eyeglass An option, and hence an integral part 21. IIa No adaptor Rule 9 of the hearing aid A detachable part, and hence an 22. Ear Hook IIa No Rule 9 integral part of the hearing aid Impression A substance that, although for material is temporary use, may have health and Impression 23. I invasive Yes safety implications. Hence classified as material material in I Rule 5 transient use ITE /custom made hearing aids are classified as IIa. Faceplates should be CE-marked. ITE/custom This refers to Article 1 (d) definitions In-the-ear made of custom made devices second (ITE) / custom 24. IIa Rule 5 hearing aids Yes section stating made hearing “Mass-produced are invasive devices which need to be adapted to aid devices meet the specific requirements of the medical practitioner or any other professional user are not considered to be custom-made devices” ITE assembly If an operator assembles ITEs 25. Custom 1.1c No In-the-ear deviating from an approved
an active device 19. Earphone (e,g used with bodyworn) IIa Rule 9 Earphone is an active device Yes An earphone directly affects the output of body worn hearing aids, and is therefore classified as IIa. It is also sold separate from the hearing aid, and must therefore be CE-marked 20. Eyeglass hearing aid (EG) IIa Rule 9 EG is an active device Yes Eyeglass hearing aids are classified as IIa 21. Eyeglass adaptor IIa Rule 9 No An option, and hence an integral part of the hearing aid 22. Ear Hook IIa Rule 9 No A detachable part, and hence an integral part of the hearing aid 23. Impression material I Rule 5 Impression material is invasive material in transient use Yes A substance that, although for temporary use, may have health and safety implications. Hence classified as I 24. In-the-ear (ITE) / custom made hearing aid IIa Rule 5 ITE/custom made hearing aids are invasive devices Yes ITE /custom made hearing aids are classified as IIa. Faceplates should be CE-marked. This refers to Article 1 (d) definitions of custom made devices second section stating “Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered to be custom-made devices” 25. ITE assembly In-the-ear Custom 1.1c No If an operator assembles ITEs deviating from an approved
Classification-Document-v14.4.docx