Tuned Self-Fitting Mobile App
FDA 510(k) clearance K251208 · decided 2025-09-26
Clearance details
- K-number
- K251208
- Device name
- Tuned Self-Fitting Mobile App
- Applicant
- Tuned , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-04-18
- Decision date
- 2025-09-26
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- SCR
- Device class
- 2
- Regulation number
- 874.3335
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Gan Yoshiya, IL
- 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 |
|---|---|---|
| Hearing Aid Feature (K261187) | Samsung Electronics Co., Ltd. | 2026-07-31 |
| Hearing assist (K254044) | Meta Platform Technologies, LLC | 2026-07-13 |
| Nuance Audio Hearing Aid Software (K243150) | Luxottica Group S.P.A. | 2025-01-31 |
| Hearing Aid Feature (HAF) (DEN230081) | Apple, Inc. | 2024-09-12 |
Recalls involving this device
No recalls on record reference this clearance.