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FDA 510(k)

TRANSEAR BONE CONDUCTION HEARING AID

K-Number: K050653 · 2005-07-01

ApplicantUnited Hearing Systems, Inc.
Decision Date2005-07-01
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TRANSEAR BONE CONDUCTION HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is United Hearing Systems, Inc.. It received FDA 510(k) clearance on 2005-07-01 under 510(k) number K050653. 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 TRANSEAR BONE CONDUCTION HEARING AID?

TRANSEAR BONE CONDUCTION HEARING AID is a medical device that received FDA 510(k) clearance on 2005-07-01. The listed applicant is United Hearing Systems, Inc.. The 510(k) number is K050653.

When did TRANSEAR BONE CONDUCTION HEARING AID receive FDA 510(k) clearance?

TRANSEAR BONE CONDUCTION HEARING AID received FDA 510(k) clearance on 2005-07-01, under 510(k) number K050653.

Who is the listed applicant for TRANSEAR BONE CONDUCTION HEARING AID?

The FDA 510(k) record lists United Hearing Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSEAR BONE CONDUCTION HEARING AID?

The FDA product code for TRANSEAR BONE CONDUCTION HEARING AID 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing United Hearing Systems, Inc. as applicant

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.

K970828UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMERK892803PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911

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.

K253431Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)Shokz Health Global LimitedK254296Ossiclear (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 Mbh

Official Source

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

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