§ 874.3300 - Air-conduction hearing aid.

§ 874.3300 Hearing Aid.

Cross Reference

Link to an amendment published at 87 FR 50762, Aug. 17, 2022.

Air-conduction hearing aid.

(a) Identification. A An air-conduction hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing . This generic type of device includes the airthat conducts sound to the ear through the air. An air-conduction hearing aid and the boneis subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid , but generic type excludes the group hearing aid or group auditory trainer (§ 874.3320), master hearing aid (§ , and the tinnitus masker, regulated under §§ 874.3320, 874.3330), and tinnitus masker (§ 874.3400), respectively.

(b) Classification.

(1)

Class I (general controls)

for the air-conduction hearing aid. The air-conduction hearing aid

. This device is exempt from

the

premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.

(2) Class II for the bone-conduction hearing aid.

[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000[87 FR 50762, Aug. 17, 2022]