§ 874.3950. Transcutaneous air conduction hearing aid system.
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/us/cfr/t21/s§ 874.3950·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A transcutaneous air conduction hearing aid system is a wearable sound-amplifying device intended to compensate for impaired hearing without occluding the ear canal. The device consists of an air conduction hearing aid attached to a surgically fitted tube system, which is placed through soft tissue between the post auricular region and the outer ear canal. A transcutaneous air conduction hearing aid system is subject to the requirements in § 801.422 of this chapter.
(b)Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA.” See § 874.1 for the availability of this guidance document. [67 FR 67790, Nov. 7, 2002, as amended at 87 FR 50762, Aug. 17, 2022]
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§ 874.3950
Transcutaneous air conduction hearing aid system.
Fed. Reg.×2
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