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Hearing Aid, Air-Conduction, Prescription

FDA product code ESD · 1367 cleared devices

Class 1 Ear, Nose, Throat
Regulation
21 CFR 874.3300
Review panel
EN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1976-07-21 – 2024-04-11

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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