NIX · Class II · 21 CFR 874.3950

FDA Product Code NIX: Hearing Aid, Air Conduction, Transcutaneous System

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.

Leading manufacturers include Auric Hearing Systems, Inc. and Gyrus Ent LLC.

2
Total
1
Cleared
93d
Avg days
2002
Since

FDA 510(k) Cleared Hearing Aid, Air Conduction, Transcutaneous System Devices (Product Code NIX)

2 devices
1–2 of 2
Cleared Aug 20, 2004
RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM
K040996
Gyrus Ent LLC
Ear, Nose, Throat · 126d
Not Cleared Aug 20, 2002
RETROX
DEN020003
Auric Hearing Systems, Inc.
Ear, Nose, Throat · 60d

About Product Code NIX - Regulatory Context