NIX — Hearing Aid, Air Conduction, Transcutaneous System Class II

FDA Device Classification

Classification Details

Product Code
NIX
Device Class
Class II
Regulation Number
874.3950
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
Yes

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K040996gyrus entRETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARINGAugust 20, 2004
DEN020003auric hearing systemsRETROXAugust 20, 2002