ESD

Hearing Aid, Air-Conduction, Prescription

Product code

ESD

Device name

Hearing Aid, Air-Conduction, Prescription

Device class

Class 1

21 CFR

21 CFR 874.3300

Medical specialty

Ear, Nose, Throat

Marketing pathway

510(K) Exempt

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

1367 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-04-11.

1 summaries are archived here for direct download.