and tinnitus masker (874.3400) wearable device, (special controls). The special Wireless intended to compensate controls for this device are for impaired hearing OSM Exempted (see 874.3305) 9.1 Class 2 874.3305 (BTE) that incorporates from 510k hearing aids wireless technology in its programming or use. A hearing aid is wearable (1) Class I (general controls) device that is for the air-conduction hearing intended to compensate aid. The air-conduction for impaired hearing. hearing aid is exempt from the This generic type of premarket notification device includes the procedures in subpart E of Body-worn hearing aid part 807 of this chapter Exempted 10. hearing aids Class 1 874.3300 and the ESD subject to 874.9. from 510k (BW) hearing aid, but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400) Charger 11. No No Multipurpose product and (for rechargeable though not an accessory batteries) Manufacturers can decide to Charger 12 No No classify as MD or not. If (designed for
and tinnitus masker (874.3400) 9.1 Wireless (BTE) hearing aids Class 2 874.3305 wearable device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. OSM Exempted from 510k (special controls). The special controls for this device are (see 874.3305) 10. Body-worn hearing aids (BW) Class 1 874.3300 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 Exempted from 510k (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. 11. Charger (for rechargeable batteries) No No Multipurpose product and though not an accessory 12 Charger (designed for No No Manufacturers can decide to classify as MD or not. If
Classification-Document-v14.4.docx