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)— 510(k) K260452
Substantially EquivalentZdeer Technology (Henan) Co., Ltd.
FDA 510(k) clearance K260452 for 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), Substantially Equivalent on 2026-06-15. Applicant: Zdeer Technology (Henan) Co., Ltd.. Device class: 2.
Summary
Zdeer Technology (Henan)'s Bone Conduction Hearing Aid is listed in 38 models, numbered in the G41, G42, G43, G45, and G46 series. It's filed under LXB, bone conduction hearing aids, and the record doesn't say how the models differ.
Class II, 21 CFR 874.3302. Ear, Nose, and Throat is both the classification panel and the review panel. It was a Traditional 510(k).
Zdeer filed from Changge, Xuchang City, China. Review took 124 calendar days (February 11 to June 15, 2026).
Clearance details
- Applicant
- Zdeer Technology (Henan) Co., Ltd.
- 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
- Changge, Xuchang City, CN
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)
- K254296 — Ossiclear (Ossiclear System)
- 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
More clearances from Zdeer Technology (Henan) Co., Ltd.
view allAdverse 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.