21 CFR 874.1070 — Adaptor, Short Increment Sensitivity Index (Sisi)
Ear, Nose, Throat (EN) · Part 874 Subpart B—Diagnostic Devices · § 874.1070
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ETR | Adaptor, Short Increment Sensitivity Index (Sisi) | 1 | 0 |
