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FDA 510(k)

HEARING AID

K-Number: K870982 · 1987-03-30

ApplicantAudioear Electronics
Decision Date1987-03-30
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Audioear Electronics. It received FDA 510(k) clearance on 1987-03-30 under 510(k) number K870982. 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?

HEARING AID is a medical device that received FDA 510(k) clearance on 1987-03-30. The listed applicant is Audioear Electronics. The 510(k) number is K870982.

When did HEARING AID receive FDA 510(k) clearance?

HEARING AID received FDA 510(k) clearance on 1987-03-30, under 510(k) number K870982.

Who is the listed applicant for HEARING AID?

The FDA 510(k) record lists Audioear Electronics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEARING AID?

The FDA product code for 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

Related PubMed Literature

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.

PMID: 28005723Light-Driven Contact Hearing Aid for Broad-Spectrum Amplification: Safety and Effectiveness Pivotal Study.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology ()

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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