ETR · Adaptor, Short Increment Sensitivity Index (Sisi)
Ear, Nose, Throat · 21 CFR 874.1070 · Class 1
Overview
| Product Code | ETR |
|---|---|
| Device Name | Adaptor, Short Increment Sensitivity Index (Sisi) |
| Regulation | 21 CFR 874.1070 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
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.
