FDA product code QDD: Self-Fitting Air-Conduction Hearing Aid, Prescription
QDD is the FDA product code for self-fitting air-conduction hearing aid, prescription. It is a Class II device, regulated under 21 CFR 874.3325 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 6 510(k) submissions under QDD, 5 in the last five years, from 6 different applicants. The average 510(k) review took 153 days (median 162). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Self-Fitting Air-Conduction Hearing Aid, Prescription |
| Device class | Class II |
| Regulation | 21 CFR 874.3325 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for QDD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 30 |
| 2022 | 4 | 149 |
| 2023 | 1 | 292 |
Compare with all 510(k) review times · Search every QDD clearance
Top QDD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intricon Corporation | 1 | 2023-10-17 |
| Wsaud A/S | 1 | 2022-08-12 |
| Mdhearingaid | 1 | 2022-08-04 |
| GN Hearing A/S | 1 | 2022-01-19 |
| Kaz USA, Inc., A Helen of Troy Company | 1 | 2022-01-05 |
1 more applicants have QDD clearances. See the full list in Caduvo.
Most recent QDD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223911 | Intricon Corporation | Lumen 155-SF | 2023-10-17 | 292 |
| K220403 | Wsaud A/S | Vibe SF Self-Fitting Hearing Aid | 2022-08-12 | 182 |
| K220303 | Mdhearingaid | MDHearingAid app, MDHearingAid Smart hearing aids | 2022-08-04 | 183 |
| K213424 | GN Hearing A/S | Jabra Enhance Plus | 2022-01-19 | 90 |
| K212609 | Kaz USA, Inc., A Helen of Troy Company | BHA100 Series Braun Clear Hearing Aid | 2022-01-05 | 141 |
Recalls for QDD devices
openFDA lists no recalls for product code QDD.
Frequently asked questions
What is FDA product code QDD?
QDD is the FDA product code for self-fitting air-conduction hearing aid, prescription. It is a Class II device, regulated under 21 CFR 874.3325 and reviewed by the Ear, Nose and Throat panel.
What device class is QDD?
Class II, regulation 21 CFR 874.3325. Typical premarket route: 510(k).
How long does a 510(k) take for product code QDD?
Across 6 cleared submissions the average was 153 days from receipt to decision (median 162).
Which companies have the most QDD clearances?
Intricon Corporation (1); Wsaud A/S (1); Mdhearingaid (1); GN Hearing A/S (1); Kaz USA, Inc., A Helen of Troy Company (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QDD
- Run a recall and safety report across every QDD manufacturer
- Watch product code QDD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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