Panels › Ear, Nose, Throat › Product code QUH · Class 2
Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Regulation 874.3325
1510(k)s in 12 months (10 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QUH
| Company | 510(k)s | Recalls |
|---|---|---|
| Concha Labs | 1 | 0 |
| Eargo, Inc. | 1 | 0 |
| GN Hearing A/S | 1 | 0 |
| Hearx SA (Pty) , Ltd. | 1 | 0 |
| Huizhou Jinghao Medical Technology Co., Ltd. | 1 | 0 |
| Nuheara Limited | 1 | 0 |
| Sonova AG | 1 | 0 |
| Soundwave Hearing, LLC | 1 | 0 |
| Tuned , Ltd. | 1 | 0 |
| Wsaud A/S | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 25, 2026 | K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) GN Hearing A/S, DK | QUH |
| Mar 15, 2024 | K233747 | Concha Sol Hearing Aids (CL-1001) Concha Labs | QUH |
| Feb 9, 2024 | K233464 | WSA Self-Fitting Hearing Aid Gen 2 Wsaud A/S, DK | QUH |
| Oct 26, 2023 | K231550 | Sontro® OTC Hearing Aids (AI) Soundwave Hearing, LLC | QUH |
| Sep 25, 2023 | K221052 | Self-Fitting hearing aids Huizhou Jinghao Medical Technology Co., Ltd., CN | QUH |
| Sep 8, 2023 | K223848 | Intrisound Tuned Lumen® 155 Hearing Aids Tuned , Ltd., IL | QUH |
| Jun 16, 2023 | K230538 | All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid Sonova AG, CH | QUH |
| Mar 14, 2023 | K223137 | Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application Hearx SA (Pty) , Ltd., ZA | QUH |
| Dec 21, 2022 | K221698 | Eargo 5 , Eargo 6 Eargo, Inc. | QUH |
| Oct 30, 2022 | K221064 | Nuheara IQbuds 2 PRO Hearing Aid Nuheara Limited | QUH |
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