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FDA 510(k)

IN-TH-EAR HEARING AID

K-Number: K850123 · 1985-03-21

ApplicantGeneral Hearing Instruments, Inc.
Decision Date1985-03-21
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IN-TH-EAR HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is General Hearing Instruments, Inc.. It received FDA 510(k) clearance on 1985-03-21 under 510(k) number K850123. 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 IN-TH-EAR HEARING AID?

IN-TH-EAR HEARING AID is a medical device that received FDA 510(k) clearance on 1985-03-21. The listed applicant is General Hearing Instruments, Inc.. The 510(k) number is K850123.

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

IN-TH-EAR HEARING AID received FDA 510(k) clearance on 1985-03-21, under 510(k) number K850123.

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

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

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

The FDA product code for IN-TH-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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing General Hearing Instruments, 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.

K061459TRANQUIL TRI-BTEK974751TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CICK971399AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CICK943144AURIS CIC

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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