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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Bone Conduction
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.
East Of Wei Wu Rd. And S. Of Qin Gong E. Rd.,
Toubao Village Committee, Laotown Town
Changge, Xuchang City,  CN 461500
Applicant Contact Wenlin Xiang
Correspondent
Zdeer Technology (Henan) Co., Ltd.
East Of Wei Wu Rd. And S. Of Qin Gong E. Rd.,
Toubao Village Committee, Laotown Town
Changge, Xuchang City,  CN 461500
Correspondent Contact Wenlin Xiang
Regulation Number874.3302
Classification Product Code
LXB  
Date Received02/11/2026
Decision Date 06/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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