510(k) DEN020003
DEN020003 is an FDA 510(k) premarket notification submitted by Auric Hearing Systems, Inc. for the device "RETROX". The FDA issued a decision of De Novo Granted on August 20, 2002. The device falls under product code NIX (Hearing Aid, Air Conduction, Transcutaneous System), a Class II device regulated under 21 CFR 874.3950.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 20, 2002
- Date Received
- June 21, 2002
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hearing Aid, Air Conduction, Transcutaneous System
- Device Class
- Class II
- Regulation Number
- 874.3950
- Review Panel
- EN
- Submission Type
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.