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FDA 510(k)

HEARING AID (ALL-IN-THE-EAR)

K-Number: K953960 · 1995-09-12

ApplicantAudina Hearing Instrument
Decision Date1995-09-12
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARING AID (ALL-IN-THE-EAR) is the device name listed in this FDA 510(k) record. The listed applicant is Audina Hearing Instrument. It received FDA 510(k) clearance on 1995-09-12 under 510(k) number K953960. 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 (ALL-IN-THE-EAR)?

HEARING AID (ALL-IN-THE-EAR) is a medical device that received FDA 510(k) clearance on 1995-09-12. The listed applicant is Audina Hearing Instrument. The 510(k) number is K953960.

When did HEARING AID (ALL-IN-THE-EAR) receive FDA 510(k) clearance?

HEARING AID (ALL-IN-THE-EAR) received FDA 510(k) clearance on 1995-09-12, under 510(k) number K953960.

Who is the listed applicant for HEARING AID (ALL-IN-THE-EAR)?

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

What is the FDA product code for HEARING AID (ALL-IN-THE-EAR)?

The FDA product code for HEARING AID (ALL-IN-THE-EAR) 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 Audina Hearing Instrument 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.

K964816AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EARK942236AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)K936190BEHIND THE EAR HEARING AIDK930271BEHIND-THE-EAR HEARING AIDK897024MODEL AUDINA ITE HEATING AIDK897023OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID

View all 8 devices →

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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