Hearing Aid, Air-Conduction, Over The Counter
The Hearing Aid, Air-Conduction, Over The Counter is a wearable sound-amplifying device intended to compensate for impaired hearing by conducting amplified sound to the ear through the air, available without a prescription under the FDA's Over-the-Counter Hearing Aid regulatory framework established by the 2022 final rule (87 FR 50698). This classification makes hearing aids directly accessible to adults with mild to moderate hearing loss. Classified as FDA Class 1 under regulation 874.3300, it is subject to general controls and is 510(k) exempt in the Ear, Nose, and Throat specialty. It is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QUF
- Device Class
- FDA class 1
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
Definition
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. This is an over the counter hearing aid. For information on the final rule Establishing Over-the-Counter Hearing Aids, please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf.
FEI Numbers
This FDA classification entry is associated with 84 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 84 registration numbers. Click on an entry to view related FDA registrations.