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Retrox

by Auric Hearing Systems, Inc.

De Novo DEN020003

Active United States

De Novo

Valid until

No expiry

De Novo grant 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 De Novo, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Post-NSE NumberDEN020003 Date20 Aug 2002DecidedStatusActive

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  • Withdrawn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 De Novo Active

Specification

De Novo

De Novo Number
FDA Product Code
NIX
Device Class
Class II
Regulation
21 CFR Part 874.3950
Advisory Committee
Ear, Nose, Throat
FDA Decision
DENG De Novo granted

Overview

AI-generated summary, 27 Sep 2026

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

The Retrox is a hearing aid, air conduction, transcutaneous system, classified as a class 2 device. It is used to amplify sound directly to the ear canal. The device consists of a component placed via functional piercing in the outer ear canal.

The Retrox is supplied as a transcutaneous air conduction hearing aid system component, with a titanium tube system. It is regulated under the regulation number 874.3950, with an FDA 510K authorization, and is classified under the product code NIX.

Questions

AI-generated answers, 27 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 is the Retrox used for?

    The Retrox is used to amplify sound directly to the ear canal, functioning as a hearing aid system.

  • How is the Retrox supplied?

    The Retrox is supplied as a transcutaneous air conduction hearing aid system component, including a titanium tube system.

  • Is the Retrox a single-use or reusable device?

    The device data does not specify whether the Retrox is for single-use or reuse, but it is classified as a class 2 device with a titanium component.

  • What regulatory authorization does the Retrox have?

    The Retrox has an FDA 510K authorization, regulated under the number 874.3950, and is classified under the product code NIX.