510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040996Substantially Equivalent

Retrox Titanium Tube System for the Retrox Transcutaneous Air Conduction Hearing Aid System

Gyrus Ent LLC, Bartlett TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040996 is the FDA 510(k) clearance record for RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM, a class II device, cleared for Gyrus Ent LLC on under FDA product code NIX (Hearing Aid, Air Conduction, Transcutaneous System). FDA's definition for product code NIX reads: "The transcutaneous air conduction hearing aid system is a wearable sound-amplifying device that is intended to compensate for impaired hearing. It consists of an air conduction hearing aid attached to a surgically fitted tube system. The...". FDA records list 28 510(k) clearances for Gyrus Ent LLC, from to . As of , FDA records show no recalls naming K040996.

Clearance record

Decision date
Received
(126 days to decision)
Product code
NIX Hearing Aid, Air Conduction, Transcutaneous System
Regulation
21 CFR 874.3950
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Gyrus Ent LLC 2925 Appling Rd., Bartlett TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NIX

Trailing 12 months

FDA records hold no clearances under product code NIX in the trailing twelve months.

FDA records show no clearances under product code NIX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NIX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260