Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)— 510(k) K253431
Substantially EquivalentShokz Health Global Limited
FDA 510(k) clearance K253431 for Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN), Substantially Equivalent on 2026-08-19. Applicant: Shokz Health Global Limited. Device class: 2.
Summary
Shokz Health Global's Bone conduction Hearing Aid lists nine models, from BM100 through SHOKZHEAR BM420MN. The product code is LXB, bone conduction hearing aids.
Class II, 21 CFR 874.3302. Ear, Nose, Throat is both the classification panel and the review panel. It was a Traditional 510(k).
Shokz filed from Kowloon, Hong Kong. The decision came 322 calendar days after FDA received it (October 1, 2025 to August 19, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Shokz Health Global Limited
- 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
- Kowloon, HK
Recent devices under product code LXB
view all- K254296 — Ossiclear (Ossiclear System)
- 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.