Cleared Traditional

K040996 - RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM (FDA 510(k) Clearance)

K040996 · Gyrus Ent LLC · Ear, Nose, Throat device
Aug 2004
Decision
126d
Days
Class 2
Risk

K040996 is an FDA 510(k) clearance for the RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM. This device is classified as a Hearing Aid, Air Conduction, Transcutaneous System (Class II - Special Controls, product code NIX).

Submitted by Gyrus Ent LLC (Bartlett, US). The FDA issued a Cleared decision on August 20, 2004, 126 days after receiving the submission on April 16, 2004.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3950. 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..

Submission Details

510(k) Number K040996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2004
Decision Date August 20, 2004
Days to Decision 126 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code NIX — Hearing Aid, Air Conduction, Transcutaneous System
Device Class Class II - Special Controls
CFR Regulation 21 CFR 874.3950
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.