DeviceClearance

Product code ESD— Ear, Nose, Throat

HEARING AID (ALL-IN-THE-EAR)

Classification name
Hearing Aid, Air-Conduction, Prescription
Device class
Class 1
Regulation
21 CFR 874.3300
Advisory panel
Ear, Nose, Throat
Total cleared
1,367
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code ESD under 21 CFR 874.3300, via openFDA

Market context for product code ESD

FDA has cleared 1,367 devices under product code ESD between 1976 and 2024, filed by 260 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code ESD

Recent clearances under product code ESD

1–100 of 1,367

Data sourced from openFDA. This site is unofficial and independent of the FDA.