Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
- US Product Code (FDA)
- QUGView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 874.3305View CFR Regulation →
- Medical specialty
- Ear, Nose, Throat
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. 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.
Click to search for similar devices in our global database
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter is a medical device type in the Ear, Nose, Throat specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.