A hearing aid is A bone conductor directly wearable affects the output of hearing device that is aids.. intended to compensate for impaired hearing. This generic type of device includes the Bone conduction hearing aid LXB not 8. Conductor 2 874.3300 and the exempted (no implant) hearing aid, from 510k but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400) 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 Exempted 9. (BTE) Class 1 874.3300 hearing aid part 807 of this chapter from 510k hearing aids and the subject to 874.9. hearing aid, ESD but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330),
8. Bone Conductor (no implant) 2 874.3300 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) LXB not exempted from 510k A bone conductor directly affects the output of hearing aids.. 9. (BTE) hearing aids 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), 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. conduction
Classification-Document-v14.4.docx