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FDA 510(k)

MODEL C-1 HEARING AID

K-Number: K973043 · 1997-10-27

ApplicantBetter Hearing, Inc.
Decision Date1997-10-27
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL C-1 HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Better Hearing, Inc.. It received FDA 510(k) clearance on 1997-10-27 under 510(k) number K973043. 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 MODEL C-1 HEARING AID?

MODEL C-1 HEARING AID is a medical device that received FDA 510(k) clearance on 1997-10-27. The listed applicant is Better Hearing, Inc.. The 510(k) number is K973043.

When did MODEL C-1 HEARING AID receive FDA 510(k) clearance?

MODEL C-1 HEARING AID received FDA 510(k) clearance on 1997-10-27, under 510(k) number K973043.

Who is the listed applicant for MODEL C-1 HEARING AID?

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

What is the FDA product code for MODEL C-1 HEARING AID?

The FDA product code for MODEL C-1 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 Better Hearing, 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.

K971298BETTER HEARING, INC. MODEL L-1 HEARING 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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