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FDA 510(k)

CUSTOM IN-THE-EAR HEARING AID

K-Number: K811719 · 1981-07-27

ApplicantHearing Health Group, Inc.
Decision Date1981-07-27
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CUSTOM IN-THE-EAR HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Hearing Health Group, Inc.. It received FDA 510(k) clearance on 1981-07-27 under 510(k) number K811719. 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 CUSTOM IN-THE-EAR HEARING AID?

CUSTOM IN-THE-EAR HEARING AID is a medical device that received FDA 510(k) clearance on 1981-07-27. The listed applicant is Hearing Health Group, Inc.. The 510(k) number is K811719.

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

CUSTOM IN-THE-EAR HEARING AID received FDA 510(k) clearance on 1981-07-27, under 510(k) number K811719.

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

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

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

The FDA product code for CUSTOM 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

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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