NIX
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Hearing Aid, Air Conduction, Transcutaneous System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3950
- Medical specialty
- Ear, Nose, Throat
- Flags
- Implant
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM (K040996) | Gyrus Ent LLC | 2004-08-20 |
| RETROX (DEN020003) | Auric Hearing Systems, Inc. | 2002-08-20 |
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Every clearance here is in the API, with alerts when new ones post.