C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 874—EAR, NOSE, AND THROAT DEVICES › Subpart D—Prosthetic Devices

21 C.F.R. § 874.3300

Air-conduction hearing aid

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

(b) Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.

[87 FR 50762, Aug. 17, 2022]
Notes of Decisions
Cited in 5 cases, 1995–2007 · leading case: Kernats v. Smith Indus. Med. Sys., Inc., 669 N.E.2d 1300 (Ill. App. Ct. 1996).
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Kernats v. Smith Indus. Med. Sys., Inc., 669 N.E.2d 1300 (Ill. App. Ct. 1996). “§ 360c(a)(1)(B); 21 C.F.R. § 874.3300 (1995). Class III devices, applying to the CVS catheter in this case, present "a potential unreasonable risk of illness or injury," and are subject to the most stringent MDA controls.”
Duvall v. Bristol-Myers-Squibb Co., 103 F.3d 324 (4th Cir. 1997). “§ 360c(a)(1)(B); 21 C.F.R. § 874.3300 (1996). Class III devices are those devices: (1) for which there is insufficient information to determine that the controls applicable to Class I and II devices are alone enough to provide reasonable assurance of the safety and effectiveness…”
Duvall v. Bristol-Myers-Squibb Co., 65 F.3d 392 (4th Cir. 1995). “§ 360c(a)(l)(B); 21 C.F.R. § 874.3300 (1994). Class III devices are those devices: (1) for which there is insufficient information to determine that the controls applicable to Class I and II devices are alone enough to provide reasonable assurance of the safety and effectiveness…”
Rattay v. Medtronic, Inc., 482 F. Supp. 2d 746 (N.D.W. Va. 2007). “§ 360c (a)(1)(B); 21 C.F.R. § 874.3300 (1996). Class III devices are those devices: (1) for which there is insufficient information to determine that the controls applicable to Class I and II devices are alone enough to provide reasonable assurance of the safety and…”
Kernats v. Smith Indus. Med. Sys., Inc., 283 Ill. App. 3d 455 (Ill. App. Ct. 1996). “§ 360c(a)(1)(B) (1988); 21 C.F.R. § 874.3300 (1995). Class III devices, applying to the CVS catheter in this case, present "a potential unreasonable risk of illness or injury” and are subject to the most stringent MDA controls.”
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