Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911

K-Number: K892803 · 1989-06-22

ApplicantUnited Hearing Systems, Inc.
Decision Date1989-06-22
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911 is the device name listed in this FDA 510(k) record. The listed applicant is United Hearing Systems, Inc.. It received FDA 510(k) clearance on 1989-06-22 under 510(k) number K892803. 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 PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911?

PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911 is a medical device that received FDA 510(k) clearance on 1989-06-22. The listed applicant is United Hearing Systems, Inc.. The 510(k) number is K892803.

When did PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911 receive FDA 510(k) clearance?

PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911 received FDA 510(k) clearance on 1989-06-22, under 510(k) number K892803.

Who is the listed applicant for PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911?

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

What is the FDA product code for PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911?

The FDA product code for PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911 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 United Hearing Systems, 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.

K050653TRANSEAR BONE CONDUCTION HEARING AIDK970828UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER

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.

↑