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FDA 510(k)

HSI ELITE #EC CUSTOM CANAL HEAR-AID

K-Number: K832701 · 1983-09-29

ApplicantHearing Services, Inc.
Decision Date1983-09-29
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HSI ELITE #EC CUSTOM CANAL HEAR-AID is the device name listed in this FDA 510(k) record. The listed applicant is Hearing Services, Inc.. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K832701. 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 HSI ELITE #EC CUSTOM CANAL HEAR-AID?

HSI ELITE #EC CUSTOM CANAL HEAR-AID is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is Hearing Services, Inc.. The 510(k) number is K832701.

When did HSI ELITE #EC CUSTOM CANAL HEAR-AID receive FDA 510(k) clearance?

HSI ELITE #EC CUSTOM CANAL HEAR-AID received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832701.

Who is the listed applicant for HSI ELITE #EC CUSTOM CANAL HEAR-AID?

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

What is the FDA product code for HSI ELITE #EC CUSTOM CANAL HEAR-AID?

The FDA product code for HSI ELITE #EC CUSTOM CANAL HEAR-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 Hearing Services, 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.

K871884IN THE EAR & IN THE CANAL HEARING AID FACE PLATEK790737HSI MODEL C. CUSTOM IN-THE-EAR HEAR/AID

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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