FDA product code ESD

Hearing Aid, Air-Conduction, Prescription

Ear, Nose, Throat·Class 1·21 CFR 874.3300
US regulatory classifications
US Product Code (FDA)
ESD
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 874.3300
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Medical specialty
Ear, Nose, Throat
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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 a prescription hearing aid.

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About this record

Hearing Aid, Air-Conduction, Prescription 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.