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FDA 510(k)

FACEPLATE (HEARING AID KIT)

K-Number: K954236 · 1995-12-06

ApplicantTruetone Hearing Systems, Inc.
Decision Date1995-12-06
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FACEPLATE (HEARING AID KIT) is the device name listed in this FDA 510(k) record. The listed applicant is Truetone Hearing Systems, Inc.. It received FDA 510(k) clearance on 1995-12-06 under 510(k) number K954236. 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 FACEPLATE (HEARING AID KIT)?

FACEPLATE (HEARING AID KIT) is a medical device that received FDA 510(k) clearance on 1995-12-06. The listed applicant is Truetone Hearing Systems, Inc.. The 510(k) number is K954236.

When did FACEPLATE (HEARING AID KIT) receive FDA 510(k) clearance?

FACEPLATE (HEARING AID KIT) received FDA 510(k) clearance on 1995-12-06, under 510(k) number K954236.

Who is the listed applicant for FACEPLATE (HEARING AID KIT)?

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

What is the FDA product code for FACEPLATE (HEARING AID KIT)?

The FDA product code for FACEPLATE (HEARING AID KIT) 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 Truetone 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.

K945710IN-THE-EAR HEARING AID

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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