21 CFR 874.3302 — Hearing Aid, Bone Conduction
Ear, Nose, Throat (EN) · Part 874 Subpart D—Prosthetic Devices · § 874.3302
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.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LXB | Hearing Aid, Bone Conduction | 2 | 49 | 3rd Party |
| MAH | Hearing Aid, Bone Conduction, Implanted | 2 | 11 | Implant |
