510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN020003Unknown

Retrox

Auric Hearing Systems, Inc., Nahant MA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN020003 is the FDA 510(k) clearance record for RETROX, a class II device, cleared for Auric Hearing Systems, Inc. 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 one 510(k) clearance for Auric Hearing Systems, Inc. As of , FDA records show no recalls naming DEN020003.

Clearance record

Decision date
Received
(60 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
Auric Hearing Systems, Inc. 8 Fenno Way, Nahant MA
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