Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart B — Diagnostic Devices](/submissions/EN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 874.1070](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1070) → ETR — Adaptor, Short Increment Sensitivity Index (Sisi)

# ETR · Adaptor, Short Increment Sensitivity Index (Sisi)

_Ear, Nose, Throat · 21 CFR 874.1070 · Class 1_

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

## Overview

- **Product Code:** ETR
- **Device Name:** Adaptor, Short Increment Sensitivity Index (Sisi)
- **Regulation:** [21 CFR 874.1070](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1070)
- **Device Class:** 1
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## Identification

A short increment sensitivity index (SISI) adapter is a device used with an audiometer in diagnostic hearing evaluations. A SISI adapter provides short periodic sound pulses in specific small decibel increments that are intended to be superimposed on the audiometer's output tone frequency.

## 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/ETR](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETR)

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