510(k) K254296
K254296 is an FDA 510(k) premarket notification submitted by Sounduct for the device "Ossiclear (Ossiclear System)". The FDA issued a decision of Substantially Equivalent on July 22, 2026. The device falls under product code LXB (Hearing Aid, Bone Conduction), a Class II device regulated under 21 CFR 874.3302.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2026
- Date Received
- December 31, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hearing Aid, Bone Conduction
- Device Class
- Class II
- Regulation Number
- 874.3302
- Review Panel
- EN
- Submission Type