Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart B — Diagnostic Devices](/submissions/EN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 874.1100](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1100) → ETT — Cushion, Earphone (For Audiometric Testing)

# ETT · Cushion, Earphone (For Audiometric Testing)

_Ear, Nose, Throat · 21 CFR 874.1100 · Class 1_

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

## Overview

- **Product Code:** ETT
- **Device Name:** Cushion, Earphone (For Audiometric Testing)
- **Regulation:** [21 CFR 874.1100](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1100)
- **Device Class:** 1
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## Identification

An earphone cushion for audiometric testing is a device that is used to cover an audiometer earphone during audiometric testing to provide an acoustic coupling (sound connection path) between the audiometer earphone and the patient's ear.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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