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FDA 510(k)

NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)

K-Number: K972039 · 1997-08-25

ApplicantNu-Sound
Decision Date1997-08-25
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC) is the device name listed in this FDA 510(k) record. The listed applicant is Nu-Sound. It received FDA 510(k) clearance on 1997-08-25 under 510(k) number K972039. 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 NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)?

NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC) is a medical device that received FDA 510(k) clearance on 1997-08-25. The listed applicant is Nu-Sound. The 510(k) number is K972039.

When did NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC) receive FDA 510(k) clearance?

NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC) received FDA 510(k) clearance on 1997-08-25, under 510(k) number K972039.

Who is the listed applicant for NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)?

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

What is the FDA product code for NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)?

The FDA product code for NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC) is ESD.

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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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