ESD · Class I — Low Risk (general controls) · Ear, Nose, Throat · 21 CFR 874.3300
Classification
FDA Product Code
ESD
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 874.3300
Review panel
EN
Medical specialty
Ear, Nose, Throat
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.