Retrox Titanium Tube System for the Retrox Transcutaneous Air Conduction Hearing Aid System
FDA 510(k) K040996 · Gyrus Ent LLC
Submission
- Device name
- Retrox Titanium Tube System for the Retrox Transcutaneous Air Conduction Hearing Aid System
- Applicant
- Gyrus Ent LLC
Bartlett, TN, US - Received
- April 16, 2004
- Decision date
- August 20, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NIX – Hearing Aid, Air Conduction, Transcutaneous System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3950
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
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…
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Questions and answers
When was Retrox Titanium Tube System for the Retrox Transcutaneous Air Conduction Hearing Aid System cleared by the FDA?
Retrox Titanium Tube System for the Retrox Transcutaneous Air Conduction Hearing Aid System (K040996) received a 510(k) decision of Substantially Equivalent on August 20, 2004, 126 days after the submission was received.
What is the product code of K040996?
The FDA product code is NIX – Hearing Aid, Air Conduction, Transcutaneous System, a Class II (moderate risk) device regulated under 21 CFR 874.3950.