WSA Self-Fitting Hearing Aid Gen 2
FDA 510(k) clearance K233464 · decided 2024-02-09
Clearance details
- K-number
- K233464
- Device name
- WSA Self-Fitting Hearing Aid Gen 2
- Applicant
- Wsaud A/S
- Decision
- Substantially Equivalent
- Date received
- 2023-10-23
- Decision date
- 2024-02-09
- Days to decision
- 109 days
- Clearance type
- Special
- Product code
- QUH
- Device class
- 2
- Regulation number
- 874.3325
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Lynge, DK
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Jabra Enhance Select Self-fit (Jabra Enhance Select 550) (K254108) | GN Hearing A/S | 2026-06-25 |
| Concha Sol Hearing Aids (CL-1001) (K233747) | Concha Labs | 2024-03-15 |
| Sontro® OTC Hearing Aids (AI) (K231550) | Soundwave Hearing, LLC | 2023-10-26 |
| Self-Fitting hearing aids (K221052) | Huizhou Jinghao Medical Technology Co., Ltd. | 2023-09-25 |
| Intrisound™ Tuned Lumen® 155 Hearing Aids (K223848) | Tuned , Ltd. | 2023-09-08 |
| All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid (K230538) | Sonova AG | 2023-06-16 |
| Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application (K223137) | Hearx SA (Pty) , Ltd. | 2023-03-14 |
| Eargo 5 , Eargo 6 (K221698) | Eargo, Inc. | 2022-12-21 |
| Nuheara IQbuds 2 PRO Hearing Aid (K221064) | Nuheara Limited | 2022-10-30 |
Recalls involving this device
No recalls on record reference this clearance.