---
kind: "section"
citation: "21 C.F.R. § 874.3310"
title: "21"
number: "874.3310"
heading: "Hearing aid calibrator and analysis system."
url: "https://uscodex.org/cfr/21/874.3310"
---

# §874.3310. Hearing aid calibrator and analysis system.

- (a) **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.
- (b) **Classification.** Class II (special controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 874.9](/cfr/21/874.9.md).

## Notes

### Amendments

[51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.

### Amendments

[51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]