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FDA 510(k)

AUDIOTONE ITE HEARING AID MODEL ZD (XT)

K-Number: K901746 · 1990-05-29

ApplicantMiracle-Ear, Inc.
Decision Date1990-05-29
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIOTONE ITE HEARING AID MODEL ZD (XT) is the device name listed in this FDA 510(k) record. The listed applicant is Miracle-Ear, Inc.. It received FDA 510(k) clearance on 1990-05-29 under 510(k) number K901746. 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 AUDIOTONE ITE HEARING AID MODEL ZD (XT)?

AUDIOTONE ITE HEARING AID MODEL ZD (XT) is a medical device that received FDA 510(k) clearance on 1990-05-29. The listed applicant is Miracle-Ear, Inc.. The 510(k) number is K901746.

When did AUDIOTONE ITE HEARING AID MODEL ZD (XT) receive FDA 510(k) clearance?

AUDIOTONE ITE HEARING AID MODEL ZD (XT) received FDA 510(k) clearance on 1990-05-29, under 510(k) number K901746.

Who is the listed applicant for AUDIOTONE ITE HEARING AID MODEL ZD (XT)?

The FDA 510(k) record lists Miracle-Ear, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUDIOTONE ITE HEARING AID MODEL ZD (XT)?

The FDA product code for AUDIOTONE ITE HEARING AID MODEL ZD (XT) is ESD.

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Other records listing Miracle-Ear, 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.

K972344MIRACLE-EAR DIGITAL BTEK972345DAHLBERG/MIRACLE-EARK972346MIRACLE-EAR ITE DIGITALK970262MULTI-CHANNEL COMPRESSION BTE (SD)K964419MIRACLE - EAR (ITE/ITC/CIC)K965049DAHLBERG (A-554)

View all 65 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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