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FDA 510(k)

CLEARTONE MODEL-1 & 2 HEARING AIDS

K-Number: K780459 · 1978-03-30

ApplicantCleartone Custom Hearing Instruments
Decision Date1978-03-30
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CLEARTONE MODEL-1 & 2 HEARING AIDS is the device name listed in this FDA 510(k) record. The listed applicant is Cleartone Custom Hearing Instruments. It received FDA 510(k) clearance on 1978-03-30 under 510(k) number K780459. 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 CLEARTONE MODEL-1 & 2 HEARING AIDS?

CLEARTONE MODEL-1 & 2 HEARING AIDS is a medical device that received FDA 510(k) clearance on 1978-03-30. The listed applicant is Cleartone Custom Hearing Instruments. The 510(k) number is K780459.

When did CLEARTONE MODEL-1 & 2 HEARING AIDS receive FDA 510(k) clearance?

CLEARTONE MODEL-1 & 2 HEARING AIDS received FDA 510(k) clearance on 1978-03-30, under 510(k) number K780459.

Who is the listed applicant for CLEARTONE MODEL-1 & 2 HEARING AIDS?

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

What is the FDA product code for CLEARTONE MODEL-1 & 2 HEARING AIDS?

The FDA product code for CLEARTONE MODEL-1 & 2 HEARING AIDS 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

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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