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510(k) K040996

RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM by Gyrus Ent LLC — Product Code NIX

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.

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