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FDA 510(k)

BEHIND THE EAR HEARING AID

K-Number: K944039 · 1994-12-23

ApplicantAudicraft Hearing Instruments
Decision Date1994-12-23
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BEHIND THE EAR HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Audicraft Hearing Instruments. It received FDA 510(k) clearance on 1994-12-23 under 510(k) number K944039. 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 BEHIND THE EAR HEARING AID?

BEHIND THE EAR HEARING AID is a medical device that received FDA 510(k) clearance on 1994-12-23. The listed applicant is Audicraft Hearing Instruments. The 510(k) number is K944039.

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

BEHIND THE EAR HEARING AID received FDA 510(k) clearance on 1994-12-23, under 510(k) number K944039.

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

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

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

The FDA product code for BEHIND THE EAR HEARING AID is ESD.

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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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