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FDA 510(k)

SECOND EAR BONE CONDUCTION HEARING AID

K-Number: K953872 · 1996-04-12

ApplicantWordcomp International Communication Group (Wicg)
Decision Date1996-04-12
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SECOND EAR BONE CONDUCTION HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Wordcomp International Communication Group (Wicg). It received FDA 510(k) clearance on 1996-04-12 under 510(k) number K953872. 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 SECOND EAR BONE CONDUCTION HEARING AID?

SECOND EAR BONE CONDUCTION HEARING AID is a medical device that received FDA 510(k) clearance on 1996-04-12. The listed applicant is Wordcomp International Communication Group (Wicg). The 510(k) number is K953872.

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

SECOND EAR BONE CONDUCTION HEARING AID received FDA 510(k) clearance on 1996-04-12, under 510(k) number K953872.

Who is the listed applicant for SECOND EAR BONE CONDUCTION HEARING AID?

The FDA 510(k) record lists Wordcomp International Communication Group (Wicg) as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for SECOND EAR BONE CONDUCTION HEARING AID is LXB.

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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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