Hearing Aid Feature V1.0
by Samsung Electronics Co., Ltd. 2 variants
Hearing Aid Feature V1.0 is a Class II device made by Samsung Electronics Co., Ltd., cleared under FDA 510(k) K261187 on 31 Jul 2026 and listed in FDA GUDID since 19 Oct 2026 (UDI-DI 08806099221355), active as of 2 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08806099221355 | Date19 Oct 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK261187 | Date31 Jul 2026 | StatusActive |
Official records
- AccessGUDID record 08806099221355
- FDA 510(k) database K261187
Across registries
- FDA 510(k) K261187 decided 31 Jul 2026 Active
- FDA GUDID UDI-DI 08806099221355 listed 19 Oct 2026 Listed
Timeline
- Cleared FDA 510(k) K261187
- Listed FDA GUDID 08806099221355
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hearing Aid Feature
- Generic name
- Air-conduction hearing aid, in-the-ear
- Model / reference
- V1.0
- Primary DI / UDI-DI
- 08806099221355
- 510(k) Number
- FDA product code
- SCR
- GMDN term
- Air-conduction hearing aid, in-the-ear
- Device class
- Class II
- Regulation number
- 874.3335
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code SCR (Air-Conduction Hearing Aid Software).
- Hearing Aid Feature (HAF) by APPLE INC.
- Nuance Audio Hearing Aid Software by Luxottica Group S.P.A.
- Hearing Aid Feature 2.0 (HAF 2.0) Feature version 2.X by APPLE INC.
- Tuned Self-Fitting Mobile App by Tuned, Ltd.
- Hearing assist by Meta Platforms Technologies, LLC
- Hearing Aid Feature by Samsung Electronics Co.,Ltd