21 CFR 874.3310 — Calibrator, Hearing Aid / Earphone And Analysis Systems
Ear, Nose, Throat (EN) · Part 874 Subpart D—Prosthetic Devices · § 874.3310
Identification
A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.
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 |
|---|---|---|---|---|
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 2 | 46 |
Special Controls
ETW — Calibrator, Hearing Aid / Earphone And Analysis Systems
*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
