FDA Product Code
FDA Product Code QUH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3325
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | GN Hearing A/S | 2026-06-25 | Traditional | PDF ↗ |
| K233747 | Concha Sol Hearing Aids (CL-1001) | Concha Labs | 2024-03-15 | Traditional | PDF ↗ |
| K233464 | WSA Self-Fitting Hearing Aid Gen 2 | Wsaud A/S | 2024-02-09 | Special | PDF ↗ |
| K231550 | Sontro® OTC Hearing Aids (AI) | Soundwave Hearing, LLC | 2023-10-26 | Traditional | PDF ↗ |
| K221052 | Self-Fitting hearing aids | Huizhou Jinghao Medical Technology Co., Ltd. | 2023-09-25 | Traditional | PDF ↗ |
| K223848 | Intrisound Tuned Lumen® 155 Hearing Aids | Tuned , Ltd. | 2023-09-08 | Traditional | PDF ↗ |
| K230538 | All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid | Sonova AG | 2023-06-16 | Traditional | PDF ↗ |
| K223137 | Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application | Hearx SA (Pty) , Ltd. | 2023-03-14 | Traditional | PDF ↗ |
| K221698 | Eargo 5 , Eargo 6 | Eargo, Inc. | 2022-12-21 | Traditional | PDF ↗ |
| K221064 | Nuheara IQbuds 2 PRO Hearing Aid | Nuheara Limited | 2022-10-30 | Traditional | PDF ↗ |
Product code QUH · Class II · Ear, Nose, Throat. Data: openFDA.