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HA/Gold Total and Partial, Regular and Offset Ossicular Replacement Prostheses

by Mednet Locator, Inc.

510(k) K001406

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001406 Date8 Aug 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ETA
Device Class
Class II
Regulation
21 CFR Part 874.3495
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Replacement, Ossicular Prosthesis, Total (per FDA nomenclature), designed for ossicular chain reconstruction in the middle ear. It includes both total and partial ossicular replacement prostheses, available in regular and offset configurations, to restore conductive hearing loss caused by ossicular discontinuity or absence.

The HA/Gold prostheses are implanted during otologic surgery and are intended for single-use. They are classified as Class II devices under FDA regulation 874.3495, with FDA 510(k) clearance (K001406) granted under the Ear, Nose, and Throat (ENT) advisory committee. Sterility and packaging details are not specified in the regulatory submission, but compliance with FDA requirements for surgical implants applies.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of hearing loss conditions is the HA/GOLD ossicular prosthesis designed to address?

    The HA/GOLD ossicular prosthesis is specifically designed for conductive hearing loss caused by ossicular chain discontinuity or absence in the middle ear. It is used during otologic surgery to reconstruct the ossicular chain, restoring sound transmission from the eardrum to the inner ear.

  • Are the HA/GOLD prostheses reusable or intended for single-use?

    The HA/GOLD prostheses are intended for single-use only, as explicitly stated in the device description. They are implanted during surgery and are not designed for reuse.

  • What configurations are available for the HA/GOLD ossicular replacement prostheses?

    The HA/GOLD prostheses come in four configurations: total and partial ossicular replacement, each available in both regular and offset designs. This variety allows surgeons to select the appropriate prosthesis based on the patient’s anatomical needs.

  • How is the HA/GOLD ossicular prosthesis regulated in the U.S.?

    The HA/GOLD ossicular prosthesis is classified as a Class II device under FDA regulation 874.3495 and holds a traditional 510(k) clearance (K001406). It was reviewed by the Ear, Nose, and Throat (ENT) advisory committee and is substantively equivalent to a predicate device, as indicated in the regulatory submission.

  • What medical specialty primarily uses the HA/GOLD ossicular prosthesis?

    The HA/GOLD ossicular prosthesis is designed for use in the field of Ear, Nose, and Throat (ENT) surgery, as reflected in its regulatory classification and advisory committee review. It is intended for otologic procedures to address ossicular chain issues.