510(k) K040996
K040996 is an FDA 510(k) premarket notification submitted by Gyrus Ent LLC for the device "RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM". The FDA issued a decision of Substantially Equivalent on August 20, 2004. The device falls under product code NIX (Hearing Aid, Air Conduction, Transcutaneous System), a Class II device regulated under 21 CFR 874.3950. Gyrus Ent LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 2004
- Date Received
- April 16, 2004
- Clearance Type
- Traditional
- 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.