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FDA 510(k)

Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)

K-Number: K253431 · 2026-08-19

ApplicantShokz Health Global Limited
Decision Date2026-08-19
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) is the device name listed in this FDA 510(k) record. The listed applicant is Shokz Health Global Limited. It received FDA 510(k) clearance on 2026-08-19 under 510(k) number K253431. The device is classified under product code LXB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)?

Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) is a medical device that received FDA 510(k) clearance on 2026-08-19. The listed applicant is Shokz Health Global Limited. The 510(k) number is K253431.

When did Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) receive FDA 510(k) clearance?

Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) received FDA 510(k) clearance on 2026-08-19, under 510(k) number K253431.

Who is the listed applicant for Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)?

The FDA 510(k) record lists Shokz Health Global Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)?

The FDA product code for Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) is LXB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02204618Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study.COMPLETEDNCT04427033The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up StudyCOMPLETEDNCT05615649Expanded Indications in the Pediatric BONEBRIDGE PopulationACTIVE_NOT_RECRUITINGNCT07130136Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant RecipientsRECRUITINGNCT07572357Clinical Evaluation of the RH210 Hearing AidRECRUITING

Related Devices (Code: LXB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254296Ossiclear (Ossiclear System)SounductK260452Bone 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.K261256Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)Shenzhen Magnet Technology Co., Ltd.K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBandCochlearK243041contact forte AlphaBhm-Tech Produktionsgesellschaft MbhK213733Ponto 5 SuperPowerOticon Medical AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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