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FDA 510(k)

HEARING AID (ALL IN THE EAR)

K-Number: K861492 · 1986-05-02

ApplicantCrystal Tone Hearing Instruments
Decision Date1986-05-02
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARING AID (ALL IN THE EAR) is the device name listed in this FDA 510(k) record. The listed applicant is Crystal Tone Hearing Instruments. It received FDA 510(k) clearance on 1986-05-02 under 510(k) number K861492. 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 HEARING AID (ALL IN THE EAR)?

HEARING AID (ALL IN THE EAR) is a medical device that received FDA 510(k) clearance on 1986-05-02. The listed applicant is Crystal Tone Hearing Instruments. The 510(k) number is K861492.

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

HEARING AID (ALL IN THE EAR) received FDA 510(k) clearance on 1986-05-02, under 510(k) number K861492.

Who is the listed applicant for HEARING AID (ALL IN THE EAR)?

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

What is the FDA product code for HEARING AID (ALL IN THE EAR)?

The FDA product code for HEARING AID (ALL IN THE EAR) 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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