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)

510(k) number: K260452
Device name: 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)
Applicant: Zdeer Technology (Henan) Co., Ltd. CN
Product code: LXB — Hearing Aid, Bone Conduction
Decision date: 2026-06-15
Date received: 2026-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Ear, Nose, Throat

PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain

Also available from FDA: K260452.pdf

Official FDA record: K260452

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.