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New Device Clearance

RetroX Transcutaneous Air Conduction Hearing Aid System - K013298

This is a brief overview of information related to FDA’s clearance to market this product. See the links below to the 510(k) Summary and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s Clearance.

Product Name: RetroX Transcutaneous Air Conduction Hearing Aid System
Manufacturer: Auric Hearing Systems, Inc.
Address: 6000 Fairview Avenue, Suite 1200, Charlotte, NC 28210
Clearance Date: August 20, 2002 (Approved Evaluation of Automatic Class III Designation)

What is it? A new type of behind-the-ear style hearing aid that works without an earmold leaving the ear canal totally open.

Figures at right show inserted tube with and without hearing aid attached.

RetroX Transcutaneous Air Conduction Hearing Aid System with tube inserted and without hearing aid attached RetroX Transcutaneous Air Conduction Hearing Aid System with tube inserted and with hearing aid attached

How does it work? This hearing aid sends sound through a surgically fitted tube that a trained doctor has placed through soft tissue between the back of the outer ear and the outer ear canal.

Figure at right shows where tube is surgically placed through the soft tissue into the ear canal.

 shows where tube is surgically placed through the soft tissue into the ear canal.

What will it accomplish? It will improve hearing by amplifying sounds while leaving the ear canal open. Hearing aids usually plug the ear canal.

When should it not be used? It should not be used if there is local inflammation or infection in the skin behind the ear or if there is injury to the ear that would make placement of the tube impossible. The wearer should avoid an activity that might cause pressure on the tube or trauma to the ear, such as contact sports, for example. The hearing aid portion must be removed before showering or swimming.

Additional information:
Information on hearing aids: http://www.nidcd.nih.gov/health/hearing/hearingaid.asp

Updated 1/07/03

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