Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ossiclear (Ossiclear System)

K-Number: K254296 · 2026-07-22

ApplicantSounduct
Decision Date2026-07-22
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Ossiclear (Ossiclear System) is the device name listed in this FDA 510(k) record. The listed applicant is Sounduct. It received FDA 510(k) clearance on 2026-07-22 under 510(k) number K254296. 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 Ossiclear (Ossiclear System)?

Ossiclear (Ossiclear System) is a medical device that received FDA 510(k) clearance on 2026-07-22. The listed applicant is Sounduct. The 510(k) number is K254296.

When did Ossiclear (Ossiclear System) receive FDA 510(k) clearance?

Ossiclear (Ossiclear System) received FDA 510(k) clearance on 2026-07-22, under 510(k) number K254296.

Who is the listed applicant for Ossiclear (Ossiclear System)?

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

What is the FDA product code for Ossiclear (Ossiclear System)?

The FDA product code for Ossiclear (Ossiclear System) is LXB.

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.

K260452Bone 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 ABK212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppCochlear Americas

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.

↑