---
kind: "section"
citation: "21 C.F.R. § 874.1050"
title: "21"
number: "874.1050"
heading: "Audiometer."
url: "https://uscodex.org/cfr/21/874.1050"
---

# §874.1050. Audiometer.

- (a) **Identification.** An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.
- (b) **Classification.** Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in [§ 874.9](/cfr/21/874.9.md).

## Notes

### Amendments

[51 FR 40389, Nov. 6, 1986, as amended at 64 FR 14831, Mar. 29, 1999]

### 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 64 FR 14831, Mar. 29, 1999]