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FDA 510(k)

SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL

K-Number: K984518 · 1999-03-12

ApplicantSonic Innovations, Inc.
Decision Date1999-03-12
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL is the device name listed in this FDA 510(k) record. The listed applicant is Sonic Innovations, Inc.. It received FDA 510(k) clearance on 1999-03-12 under 510(k) number K984518. 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 SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL?

SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL is a medical device that received FDA 510(k) clearance on 1999-03-12. The listed applicant is Sonic Innovations, Inc.. The 510(k) number is K984518.

When did SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL receive FDA 510(k) clearance?

SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL received FDA 510(k) clearance on 1999-03-12, under 510(k) number K984518.

Who is the listed applicant for SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL?

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

What is the FDA product code for SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL?

The FDA product code for SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL 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.K974751TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CICGeneral Hearing Instruments, 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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