Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart B — Diagnostic Devices](/submissions/EN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 874.1120](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1120) → ETS — Generator, Electronic Noise (For Audiometric Testing)

# ETS · Generator, Electronic Noise (For Audiometric Testing)

_Ear, Nose, Throat · 21 CFR 874.1120 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETS

## Overview

- **Product Code:** ETS
- **Device Name:** Generator, Electronic Noise (For Audiometric Testing)
- **Regulation:** [21 CFR 874.1120](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1120)
- **Device Class:** 2
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## Identification

An electronic noise generator for audiometric testing is a device that consists of a swept frequency generator, an amplifier, and an earphone. It is intended to introduce a masking noise into the non-test ear during an audiometric evaluation. The device minimizes the non-test ear's sensing of test tones and signals being generated for the ear being tested.

## 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.

## Special Controls

*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.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K813557](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETS/K813557.md) | AUDITORY STIMULATOR | Western Advanced Technology, Inc. | Jan 19, 1982 | SESE |
| [K811790](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETS/K811790.md) | OCTOTOXIC SCREENER | Western Advanced Technology, Inc. | Jul 15, 1981 | SESE |
| [K811772](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETS/K811772.md) | AUDITORY LOCALIZER | Western Advanced Technology, Inc. | Jul 15, 1981 | SESE |
| [K790064](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETS/K790064.md) | TINNITUS DEVICES | Vicon Instrument Co. | Feb 16, 1979 | SESE |
| [K771188](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETS/K771188.md) | REVERSING CLICK GENERATOR RCG6 | Teca, Inc. | Jul 14, 1977 | SESE |

## Top Applicants

- Western Advanced Technology, Inc. — 3 clearances
- Teca, Inc. — 1 clearance
- Vicon Instrument Co. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETS](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETS)

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