NIXClass II

Hearing Aid, Air Conduction, Transcutaneous System

21 CFR 874.3950 / Ear, Nose, Throat

NIX is the FDA product code for Hearing Aid, Air Conduction, Transcutaneous System, a class II device type, regulated under 21 CFR 874.3950. FDA's definition for this code 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 tube creates an air channel through the soft tissue between outer ear canal and...". As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 2004-08-20, and no recalls.

Classification record

Product code: NIX
Device name: Hearing Aid, Air Conduction, Transcutaneous System
FDA definition: 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 tube creates an air channel through the soft tissue between outer ear canal and the post-auricular region of the pinna (ear). The air conduction hearing aid attaches to the post-auricular opening of the tube, thereby transmiting amplified sound to the ear canal without occluding the canal.
Regulation: 21 CFR 874.3950
Device class: Class II
Review panel: Ear, Nose, Throat
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code NIX

By decision year

2 clearances under product code NIX with a decision year between 2002 and 2004, 2002 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code NIX by decision year
Year	Clearances
2002	1
2004	1

Applicants with the most clearances

Product code NIX

Applicants holding the most 510(k) clearances under product code NIX
Applicant	Clearances
Auric Hearing Systems, Inc.	1
Gyrus Ent LLC	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NIX.

Recent clearances

Product code NIX

Recent recalls

Product code NIX

FDA records show no recalls under product code NIX.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)