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FDA 510(k)

IN THE EAR HEARING AID

K-Number: K962388 · 1996-09-16

ApplicantUnique Hearing Technology, Inc.
Decision Date1996-09-16
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IN THE EAR HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Unique Hearing Technology, Inc.. It received FDA 510(k) clearance on 1996-09-16 under 510(k) number K962388. 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 IN THE EAR HEARING AID?

IN THE EAR HEARING AID is a medical device that received FDA 510(k) clearance on 1996-09-16. The listed applicant is Unique Hearing Technology, Inc.. The 510(k) number is K962388.

When did IN THE EAR HEARING AID receive FDA 510(k) clearance?

IN THE EAR HEARING AID received FDA 510(k) clearance on 1996-09-16, under 510(k) number K962388.

Who is the listed applicant for IN THE EAR HEARING AID?

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

What is the FDA product code for IN THE EAR HEARING AID?

The FDA product code for IN THE EAR HEARING AID 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.

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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

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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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