FDA cleared the 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) from Zdeer Technology (Henan) Co., Ltd. on Jun 15, 2026 under K260452, a traditional 510(k). The device falls under product code LXB, Hearing Aid, Bone Conduction, regulated at 21 CFR 874.3302 as a Class 2 device. The review panel was Ear, Nose, Throat.
FDA logged the submission as received on Feb 11, 2026. The decision came 124 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Zdeer Technology (Henan) Co., Ltd. has one other decision in the tracker over the last 12 months: K260899 (Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)).
Questions & Answers
What did FDA clear under K260452?
K260452 is the FDA 510(k) 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), submitted by Zdeer Technology (Henan) Co., Ltd.. FDA's decision date was Jun 15, 2026, under product code LXB (Hearing Aid, Bone Conduction).
Who makes the 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)?
Zdeer Technology (Henan) Co., Ltd., based in Changge, Xuchang City, is the applicant of record for K260452.
How long did the K260452 review take?
FDA received the submission on Feb 11, 2026 and issued its decision on Jun 15, 2026, 124 days later.