Air Conduction Hearing Aid Transcutaneous System Suppliers

  1 suppliers  
Olympus Imaging Corporation | Address: 3-1 Nishi-Shinjuku 2-chome, Shinjuku-ku, Tokyo 163-0914, Japan
www.olympus.co.jp | Phone: +81-(3)-3340-2111
FDA Registration: 8010047
Products: Flexible Endoscope Accessory Hanger, Flexible Endoscopes (FDA Code: GCQ), Flexible Endoscope Repair Parts - Biopsy Channels, Flexible Endoscope Repair Parts - Insertion Tubes, Flexible/Rigid Bronchoscope (FDA Code: EOQ), Non Rigid Laryngoscope (FDA Code: CAL), ...
Olympus Imaging Corporation specializes in medical endoscopes and surgical products,artificial bone replacement material and dental products. We also deal with microscopes and the medical information more...
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  1 Air Conduction Hearing Aid Transcutaneous System suppliers  
FDA Code / Regulation: NIX / 874.3950

A transcutaneous air conduction hearing aid system is a wearable sound-amplifying device intended to compensate for impaired hearing without occluding the ear canal. The device consists of an air conduction hearing aid attached to a surgically fitted tube system, which is placed through soft tissue between the post auricular region and the outer ear canal.

Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled "Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA." See 874.1 for the availability of this guidance document.

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