This generic type of Face aid. The air-conduction device includes the plate) hearing aid is exempt from the hearing aid premarket notification and the procedures in subpart E of hearing aid, 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 Exempted wearable OSM from 510k Faceplates have their own device, (special product code = LRB and are Wireless intended to compensate (LRB= controls). considered as a component. (ITE) / 24.1 Class 2 874.3305 for impaired hearing Face The special custom made that incorporates plate) controls for hearing aid wireless technology in this device its programming or use. are (see 874.3305) A hearing aid is Faceplates have their own wearable ESD product code = LRB and are device that is considered as a component. ITE assembly intended to compensate (LRB= (1) Class I (general controls) In-the-ear for impaired hearing. Face for the air-conduction hearing (ITE) / custom Exempted 25. Class 1 874.300 This generic type of plate) aid. The air-conduction made hearing from 510k device includes the hearing aid is exempt from the aid hearing aid premarket notification (Non WL) and the procedures in subpart E of hearing aid, part 807 of this chapter but excludes the group subject to 874.9.
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 Face plate) 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. 24.1 Wireless (ITE) / custom made hearing aid Class 2 874.3305 wearable device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. OSM (LRB= Face plate) Exempted from 510k (special controls). The special controls for this device are (see 874.3305) Faceplates have their own product code = LRB and are considered as a component. 25. ITE assembly In-the-ear (ITE) / custom made hearing aid (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 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.
Classification-Document-v14.4.docx