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FDA 510(k)

ITE HEARING AID

K-Number: K905371 · 1991-03-15

ApplicantAudicare Hearing Center
Decision Date1991-03-15
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ITE HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Audicare Hearing Center. It received FDA 510(k) clearance on 1991-03-15 under 510(k) number K905371. 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 ITE HEARING AID?

ITE HEARING AID is a medical device that received FDA 510(k) clearance on 1991-03-15. The listed applicant is Audicare Hearing Center. The 510(k) number is K905371.

When did ITE HEARING AID receive FDA 510(k) clearance?

ITE HEARING AID received FDA 510(k) clearance on 1991-03-15, under 510(k) number K905371.

Who is the listed applicant for ITE HEARING AID?

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

What is the FDA product code for ITE HEARING AID?

The FDA product code for ITE 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

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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