Hearing Aid, Air Conduction, Transcutaneous System
- US Product Code (FDA)
- NIXView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 874.3950View CFR Regulation →
- Medical specialty
- Ear, Nose, Throat
- GMP exempt
- No
- Implantable
- Yes
- Life-sustaining
- No
- Third party review
- Not Eligible
The transcutaneous air conduction hearing aid system is a wearable sound-amplifying device that is intended to compensate for impaired hearing. It consists of an air conduction hearing aid attached to a surgically fitted tube system. The tube creates an air channel through the soft tissue between outer ear canal and the post-auricular region of the pinna (ear). The air conduction hearing aid attaches to the post-auricular opening of the tube, thereby transmiting amplified sound to the ear canal without occluding the canal.
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Hearing Aid, Air Conduction, Transcutaneous System 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. This device type includes implantable products.
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.