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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 874 - EAR, Nose, and Throat Devices |
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Subpart D - Prosthetic Devices |
§ 874.3302 - Bone-conduction hearing aid.
Latest version.
- Link to an amendment published at
§ 874.3302 xxx
Cross Reference
Bone-conduction hearing aid.
(a) Identification. A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.
(b) Classification. Class II.
[87 FR 50762, Aug. 17, 2022
.]