Product code NIX— Ear, Nose, Throat
RETROX
- Classification name
- Hearing Aid, Air Conduction, Transcutaneous System
- Device class
- Class 2
- Regulation
- 21 CFR 874.3950
- Advisory panel
- Ear, Nose, Throat
- Total cleared
- 2
- First cleared
- Most recent
FDA classification 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.”
Market context for product code NIX
FDA has cleared devices under product code NIX between 2002 and 2004, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2004
- 2002
Top applicants under product code NIX
Recent clearances under product code NIX
Data sourced from openFDA. This site is unofficial and independent of the FDA.