QDDClass II

Self-Fitting Air-Conduction Hearing Aid, Prescription

21 CFR 874.3325 / Ear, Nose, Throat

QDD is the FDA product code for Self-Fitting Air-Conduction Hearing Aid, Prescription, a class II device type, regulated under 21 CFR 874.3325. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 7 510(k) clearances under this code, the most recent dated 2023-10-17, and no recalls.

Classification record

Product code: QDD
Device name: Self-Fitting Air-Conduction Hearing Aid, Prescription
FDA 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.
Regulation: 21 CFR 874.3325
Device class: Class II
Review panel: Ear, Nose, Throat
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 7
Ingested recalls: 0

Clearances, product code QDD

By decision year

7 clearances under product code QDD with a decision year between 2018 and 2023, 2022 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code QDD by decision year
Year	Clearances
2018	1
2021	1
2022	4
2023	1

Applicants with the most clearances

Product code QDD

Applicants holding the most 510(k) clearances under product code QDD
Applicant	Clearances
Bose Corporation	2
GN Hearing A/S	1
Intricon Corporation	1
Kaz USA, Inc., A Helen of Troy Company	1
Mdhearingaid	1
Wsaud A/S	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order

Recent clearances

Product code QDD

Recent recalls

Product code QDD

FDA records show no recalls under product code QDD.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)