Ossiclear (Ossiclear System)— 510(k) K254296
Substantially EquivalentSounduct
FDA 510(k) clearance K254296 for Ossiclear (Ossiclear System), Substantially Equivalent on 2026-07-22. Applicant: Sounduct. Device class: 2.
Summary
Sounduct's Ossiclear (Ossiclear System) is filed under LXB, bone conduction hearing aids. The record doesn't list the system's components.
Class II, 21 CFR 874.3302. Ear, Nose, and Throat is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Sounduct filed from Strasbourg, France. The decision came 203 calendar days after receipt (December 31, 2025 to July 22, 2026).
Clearance details
- Applicant
- Sounduct
- Product code
- Product code LXB
- Device class
- Class 2
- Regulation
- 21 CFR 874.3302
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Strasbourg, FR
Recent devices under product code LXB
view all- K253431 — Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)
- K260452 — Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)
- K261256 — Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
- K250215 — Baha 7 Sound Processor +4 more
- K243041 — contact forte Alpha
Adverse events under product code LXB
product code LXB- Injury
- 2,334
- Total
- 2,334
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.