hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400 A hearing aid is Faceplates have their own wearable product code = LRB and are device that is considered as a component. intended to compensate ESD (1) Class I (general controls) for impaired hearing. for the air-conduction hearing This generic type of (LRB= aid. The air-conduction device includes the Face hearing aid is exempt from the hearing aid plate) premarket notification ITE kit and the Exempted procedures in subpart E of 26. Class 1 874.300 (Non WL) hearing aid, from 510k part 807 of this chapter but excludes the group subject to 874.9. hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400 Maintenance Multipurpose product and tool though not an accessory 27. No No (e.g brush tool, wax guard tool etc) Multipurpose product and PC (for 28. No No though not an accessory programming)
hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400 26. ITE kit (Non WL) Class 1 874.300 A hearing aid is wearable device that is intended to compensate 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 ESD (LRB= Face plate) 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 aid. The air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 874.9. 27. Maintenance tool (e.g brush tool, wax guard tool etc) No No Multipurpose product and though not an accessory 28. PC (for programming) No No Multipurpose product and though not an accessory