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FDA 510(k)

HI SONIC 2000 DIGITAL HEARING INSTRUMENT

K-Number: K951678 · 1995-06-07

ApplicantHearing Innovations, Inc.
Decision Date1995-06-07
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HI SONIC 2000 DIGITAL HEARING INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Hearing Innovations, Inc.. It received FDA 510(k) clearance on 1995-06-07 under 510(k) number K951678. 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 HI SONIC 2000 DIGITAL HEARING INSTRUMENT?

HI SONIC 2000 DIGITAL HEARING INSTRUMENT is a medical device that received FDA 510(k) clearance on 1995-06-07. The listed applicant is Hearing Innovations, Inc.. The 510(k) number is K951678.

When did HI SONIC 2000 DIGITAL HEARING INSTRUMENT receive FDA 510(k) clearance?

HI SONIC 2000 DIGITAL HEARING INSTRUMENT received FDA 510(k) clearance on 1995-06-07, under 510(k) number K951678.

Who is the listed applicant for HI SONIC 2000 DIGITAL HEARING INSTRUMENT?

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

What is the FDA product code for HI SONIC 2000 DIGITAL HEARING INSTRUMENT?

The FDA product code for HI SONIC 2000 DIGITAL HEARING INSTRUMENT 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 Hearing Innovations, 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.

K013253HISONIC-TRD TINNITUS RELIEF DEVICEK963745MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR)

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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