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

Name: FDA 510(k) clearance K260452
Creator: U.S. Food and Drug Administration
Published: 2026-06-15

Substantially Equivalent

Zdeer 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.

Clearance details

Applicant: Zdeer Technology (Henan) Co., Ltd.
Product code: Code LXB
Device class: Class 2
Regulation: 21 CFR 874.3302
Advisory panel: Ear, Nose, Throat
Date received: 2026-02-11
Decision date: 2026-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changge, Xuchang City, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LXB

product code LXB

Injury: 2,334
Total: 2,334

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.