for impaired hearing. hearing aid is exempt from the This generic type of premarket notification device includes the procedures in subpart E of hearing aid part 807 of this chapter and the subject to 874.9. hearing aid, but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400) Classification Regulation An option, and hence an Eyeglass 21. follows the follows integral part of the hearing aid adaptor device device Classification Regulation A detachable part, and an 22. Ear Hook follows the follows integral part of the hearing aid device device A substance that, although for LDG temporary use, may have health and safety implications. Defined “Kit, Impression 510(k) 23. N/A Not earmold , impression” in material (Unclear if this relates to classified FDA data base implanted middle ear mold or to ear molds used for air hearing aids. ) A hearing aid is Faceplates have their own In-the-ear wearable ESD product code = LRB and are (ITE) / custom Exempted 24. Class 1 874.300 device that is considered as a component. made hearing from 510k intended to compensate (LRB= (1) Class I (general controls) aid for impaired hearing. for the air-conduction hearing
for impaired hearing. This generic type of device includes the hearing aid and the hearing aid, but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400) hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 874.9. 21. Eyeglass adaptor Classification follows the device Regulation follows device An option, and hence an integral part of the hearing aid 22. Ear Hook Classification follows the device Regulation follows device A detachable part, and an integral part of the hearing aid 23. Impression material N/A Not classified Defined “Kit, earmold , impression” in FDA data base LDG 510(k) A substance that, although for temporary use, may have health and safety implications. (Unclear if this relates to implanted middle ear mold or to ear molds used for air hearing aids. ) 24. In-the-ear (ITE) / custom made hearing aid Class 1 874.300 A hearing aid is wearable device that is intended to compensate for impaired hearing. ESD (LRB= Exempted from 510k Faceplates have their own product code = LRB and are considered as a component. (1) Class I (general controls) for the air-conduction hearing
Classification-Document-v14.4.docx