510(k) K261187
K261187 is an FDA 510(k) premarket notification submitted by Samsung Electronics Co., Ltd. for the device "Hearing Aid Feature". The FDA issued a decision of Substantially Equivalent on July 31, 2026. The device falls under product code SCR (Air-Conduction Hearing Aid Software), a Class II device regulated under 21 CFR 874.3335. Samsung Electronics Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2026
- Date Received
- April 10, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Air-Conduction Hearing Aid Software
- Device Class
- Class II
- Regulation Number
- 874.3335
- Review Panel
- EN
- Submission Type
Air-conduction hearing aid software is a device that is intended to be used with a compatible wearable hardware platform to compensate for impaired hearing. The software also allows for customization to the user's hearing needs. Devices in this classification are also subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. This classification does not include software that is used with hardware as part of a hearing-aid device system classified in other regulations, e.g., § 874.3300, § 874.3305, or § 874.3325.