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FDA 510(k)

MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR)

K-Number: K963745 · 1996-11-26

ApplicantHearing Innovations, Inc.
Decision Date1996-11-26
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR) 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 1996-11-26 under 510(k) number K963745. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR)?

MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR) is a medical device that received FDA 510(k) clearance on 1996-11-26. The listed applicant is Hearing Innovations, Inc.. The 510(k) number is K963745.

When did MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR) receive FDA 510(k) clearance?

MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR) received FDA 510(k) clearance on 1996-11-26, under 510(k) number K963745.

Who is the listed applicant for MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR)?

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 MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR)?

The FDA product code for MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR) is ESD.

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 DEVICEK951678HI SONIC 2000 DIGITAL HEARING INSTRUMENT

Related Devices (Code: ESD)

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.

K232999Lyric4 Hearing AidSonova AGK130790LYRIC2Phonak, LLCK081136LYRIC HEARING AIDInsound Medical, Inc.K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, Inc.

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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