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)

THE MODEL ACAPPELLA IN THE EAR HEARING AID

K-Number: K943961 · 1995-05-15

ApplicantTelex Communications, Inc.
Decision Date1995-05-15
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

THE MODEL ACAPPELLA IN THE EAR HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Telex Communications, Inc.. It received FDA 510(k) clearance on 1995-05-15 under 510(k) number K943961. 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 THE MODEL ACAPPELLA IN THE EAR HEARING AID?

THE MODEL ACAPPELLA IN THE EAR HEARING AID is a medical device that received FDA 510(k) clearance on 1995-05-15. The listed applicant is Telex Communications, Inc.. The 510(k) number is K943961.

When did THE MODEL ACAPPELLA IN THE EAR HEARING AID receive FDA 510(k) clearance?

THE MODEL ACAPPELLA IN THE EAR HEARING AID received FDA 510(k) clearance on 1995-05-15, under 510(k) number K943961.

Who is the listed applicant for THE MODEL ACAPPELLA IN THE EAR HEARING AID?

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

What is the FDA product code for THE MODEL ACAPPELLA IN THE EAR HEARING AID?

The FDA product code for THE MODEL ACAPPELLA IN THE EAR 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 Telex Communications, 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.

K984243TELEX TINNITUS-COMPANIONK982683TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSIONK964639TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-IIK963915TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSIONK961143TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40K954579TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION

View all 50 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.

↑