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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hearing aid, air conduction, transcutaneous system
Regulation Description Transcutaneous air conduction hearing aid system.
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.
Product CodeNIX
Regulation Number 874.3950
Device Class 2

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