21 CFR 874.3300 — Hearing Aid, Air-Conduction, Prescription
Ear, Nose, Throat (EN) · Part 874 Subpart D—Prosthetic Devices · § 874.3300
Identification
An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.
Classification Rationale
Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 1 | 1367 | |
| LDG | Kit, Earmold, Impression | 1 | 2 | |
| LRB | Face Plate Hearing Aid | 1 | 24 | |
| QUF | Hearing Aid, Air-Conduction, Over The Counter | 1 | 0 |
