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FDA 510(k)

BEHIND-THE-EAR HEARING AID

K-Number: K930271 · 1993-03-18

ApplicantAudina Hearing Instrument
Decision Date1993-03-18
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 Audina Hearing Instrument. It received FDA 510(k) clearance on 1993-03-18 under 510(k) number K930271. 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 1993-03-18. The listed applicant is Audina Hearing Instrument. The 510(k) number is K930271.

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

BEHIND-THE-EAR HEARING AID received FDA 510(k) clearance on 1993-03-18, under 510(k) number K930271.

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

The FDA 510(k) record lists Audina Hearing Instrument 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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Other records listing Audina Hearing Instrument 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.

K964816AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EARK953960HEARING AID (ALL-IN-THE-EAR)K942236AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)K936190BEHIND THE EAR HEARING AIDK897024MODEL AUDINA ITE HEATING AIDK897023OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID

View all 8 devices →

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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