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FDA 510(k)

LISTENAIDER II

K-Number: K952057 · 1995-06-21

ApplicantNational Hearing Aid Dist., Inc.
Decision Date1995-06-21
Product CodeLZI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LISTENAIDER II is the device name listed in this FDA 510(k) record. The listed applicant is National Hearing Aid Dist., Inc.. It received FDA 510(k) clearance on 1995-06-21 under 510(k) number K952057. The device is classified under product code LZI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LISTENAIDER II?

LISTENAIDER II is a medical device that received FDA 510(k) clearance on 1995-06-21. The listed applicant is National Hearing Aid Dist., Inc.. The 510(k) number is K952057.

When did LISTENAIDER II receive FDA 510(k) clearance?

LISTENAIDER II received FDA 510(k) clearance on 1995-06-21, under 510(k) number K952057.

Who is the listed applicant for LISTENAIDER II?

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

What is the FDA product code for LISTENAIDER II?

The FDA product code for LISTENAIDER II is LZI.

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 National Hearing Aid Dist., 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.

K971296TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05K935458AUDIPHON, MODEL H-11

Related Devices (Code: LZI)

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.

K043090EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMSPhonic Ear, Inc.K970974WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPERWilliams Sound, LLCK970340AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIERBellabK954748POCKETALKER PROWilliams Sound, LLCK934805HEARITJe Liss & Co., Inc.K904755ACOUSTIQ LISTENING DEVICEKrueger Laboratories

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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