Panels › Ear, Nose, Throat › Product code QDD · Class 2
Self-Fitting Air-Conduction Hearing Aid, Prescription
Regulation 874.3325
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QDD
| Company | 510(k)s | Recalls |
|---|---|---|
| Bose Corporation | 2 | 0 |
| GN Hearing A/S | 1 | 0 |
| Intricon Corporation | 1 | 0 |
| Kaz USA, Inc., A Helen of Troy Company | 1 | 0 |
| Mdhearingaid | 1 | 0 |
| Wsaud A/S | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 17, 2023 | K223911 | Lumen 155-SF Intricon Corporation | QDD |
| Aug 12, 2022 | K220403 | Vibe SF Self-Fitting Hearing Aid Wsaud A/S, DK | QDD |
| Aug 4, 2022 | K220303 | MDHearingAid app, MDHearingAid Smart hearing aids Mdhearingaid | QDD |
| Jan 19, 2022 | K213424 | Jabra Enhance Plus GN Hearing A/S, DK | QDD |
| Jan 5, 2022 | K212609 | BHA100 Series Braun Clear Hearing Aid Kaz USA, Inc., A Helen of Troy Company | QDD |
| May 5, 2021 | K211008 | Bose SoundControl Hearing Aids Bose Corporation | QDD |
| Oct 5, 2018 | DEN180026 | Bose Hearing Aid Bose Corporation | QDD |
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