ETT · Cushion, Earphone (For Audiometric Testing)
Ear, Nose, Throat · 21 CFR 874.1100 · Class 1
Overview
| Product Code | ETT |
|---|---|
| Device Name | Cushion, Earphone (For Audiometric Testing) |
| Regulation | 21 CFR 874.1100 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
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.
