21 CFR 874.1100 - Earphone cushion for audiometric testing.
(a)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.
(b)Classification. 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.