# K040996: Retrox Titanium Tube System for the Retrox Transcutaneous Air Conduction Hearing Aid System

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Ent LLC
- Decided: Aug 20, 2004 after 126 days
- Product code: NIX (Hearing Aid, Air Conduction, Transcutaneous System)
- Device class: 2
- Regulation: 21 CFR 874.3950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K013298: Auric Hearing Systems. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
Mild to moderate high frequency hearing loss

Source page: https://510kreport.com/device/K040996
Methodology: https://510kreport.com/methodology