Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BEHIND-THE-EAR HEARING INSTRUMENT, H54

K-Number: K790726 · 1979-05-01

ApplicantMarcon Hearing Instruments, Inc.
Decision Date1979-05-01
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BEHIND-THE-EAR HEARING INSTRUMENT, H54 is the device name listed in this FDA 510(k) record. The listed applicant is Marcon Hearing Instruments, Inc.. It received FDA 510(k) clearance on 1979-05-01 under 510(k) number K790726. 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 BEHIND-THE-EAR HEARING INSTRUMENT, H54?

BEHIND-THE-EAR HEARING INSTRUMENT, H54 is a medical device that received FDA 510(k) clearance on 1979-05-01. The listed applicant is Marcon Hearing Instruments, Inc.. The 510(k) number is K790726.

When did BEHIND-THE-EAR HEARING INSTRUMENT, H54 receive FDA 510(k) clearance?

BEHIND-THE-EAR HEARING INSTRUMENT, H54 received FDA 510(k) clearance on 1979-05-01, under 510(k) number K790726.

Who is the listed applicant for BEHIND-THE-EAR HEARING INSTRUMENT, H54?

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

What is the FDA product code for BEHIND-THE-EAR HEARING INSTRUMENT, H54?

The FDA product code for BEHIND-THE-EAR HEARING INSTRUMENT, H54 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 Marcon 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.

K823468MODEL H 37EK821042MODEL IM9K791745MODEL H44-80 BEHIND THE EAR HEARINGK791126MODEL CE-DM-II HEARING INSTRUMENTK790870MODEL H63, BEHIND-THE-EARK790779MODEL H39C-BEHING-THE-EAR HEARING INSTRU

View all 10 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.

↑