Description
This guidance document identifies applicable legal requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) for hearing aids and for personal sound amplification products (PSAPs). A lack of clarity between PSAPs and hearing aids has contributed to stakeholder and consumer confusion. This guidance is intended to describe hearing aids, PSAPs, their respective intended uses, and the regulatory requirements that apply to both types of products.
Scope & Applicability
Product Classes
6Implications of 21 CFR 801.109 for final labeling
Hearing aids available over the counter under 21 CFR 800.30
Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.
Wearable devices designed for aiding persons with impaired hearing
Hearing aids regulated as prescription devices under 21 CFR 801.422
Category of devices established through rulemaking for over-the-counter sale
Stakeholders
1Entity responsible for submitting NDINs
Related CFR Sections (3)
- 21CFR874.3300§ 874.3300 Air-conduction hearing aid.
(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. TRead full regulation →
- 21CFR800.30§ 800.30 Over-the-counter hearing aid controls.
(a) Scope. This section specifies the requirements for over-the-counter (OTC) air-conduction hearing aids. Air-conduction hearing aids that satisfy the requirements in paragraphs (c) through (f) of this section are considered “available” over the counter as section 520(q)(1)(A)(v) of the Federal FooRead full regulation →
- 21CFR801.422§ 801.422 Prescription hearing aid labeling.
(a) Scope. This section specifies the labeling requirements for prescription hearing aids. Any hearing aid that does not satisfy the requirements of § 800.30 of this chapter shall be a prescription device. Unless otherwise specified, the requirements in this section are in addition to other applicabRead full regulation →
See Also (8)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 1 ) (Status: Final)
- Compliance Guide for Cabinet X-Ray Systems (Status: Final)
- Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Product Recalls, Including Removals and Corrections: Guidance for Industry (Status: Final)
- Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff (Status: Final)
- Marketing Clearance of Diagnostic Ultrasound Systems and Transducers : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Guidance for Industry and Food and Drug Administration Staff (Status: Final)