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FDA 510(k)

TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II

K-Number: K964639 · 1997-01-21

ApplicantTelex Communications, Inc.
Decision Date1997-01-21
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II is the device name listed in this FDA 510(k) record. The listed applicant is Telex Communications, Inc.. It received FDA 510(k) clearance on 1997-01-21 under 510(k) number K964639. 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 TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II?

TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II is a medical device that received FDA 510(k) clearance on 1997-01-21. The listed applicant is Telex Communications, Inc.. The 510(k) number is K964639.

When did TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II receive FDA 510(k) clearance?

TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II received FDA 510(k) clearance on 1997-01-21, under 510(k) number K964639.

Who is the listed applicant for TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II?

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

What is the FDA product code for TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II?

The FDA product code for TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II is ESD.

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Other records listing Telex Communications, 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.

K984243TELEX TINNITUS-COMPANIONK982683TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSIONK963915TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSIONK961143TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40K954579TELEX 349 MULTI CROS W/ADAPIVE COMPRESSIONK943961THE MODEL ACAPPELLA IN THE EAR HEARING AID

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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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