21 CFR 874.1100 — Cushion, Earphone (For Audiometric Testing)
Ear, Nose, Throat (EN) · Part 874 Subpart B—Diagnostic Devices · § 874.1100
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ETT | Cushion, Earphone (For Audiometric Testing) | 1 | 0 |
