21 CFR 874.3330 — Hearing Aid, Master
Ear, Nose, Throat (EN) · Part 874 Subpart D—Prosthetic Devices · § 874.3330
Identification
A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric testing. It has adjustable acoustic output levels, such as those for gain, output, and frequency response. The device is used to select and adjust a person's wearable hearing aid.
Classification Rationale
Class II (special controls). The device is exempt from the 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 |
|---|---|---|---|---|
| KHL | Hearing Aid, Master | 2 | 7 |
Special Controls
KHL — Hearing Aid, Master
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
eCFR
