QDD

Self-Fitting Air-Conduction Hearing Aid, Prescription

Product code

QDD

Device name

Self-Fitting Air-Conduction Hearing Aid, Prescription

Device class

Class 2

21 CFR

21 CFR 874.3325

Medical specialty

Ear, Nose, Throat

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. 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: 2023-10-17.

1 summaries are archived here for direct download.