Extended-wear hearing device. (Product Marketplace).

InSound Medical, Inc., announces that the InSound XT Series Hearing Device, the first extended-wear hearing device, has received clearance from the U.S. Food and Drug Administration (FDA) as a treatment for all hearing-impaired patients except those with a profound loss. The InSound XT is worn invisibly and continuously, without removal, deep inside the ear canal for up to 4 months. By removing the social stigma associated with a visible hearing aid, the InSound XT is intended to provide the hearing impaired with a richer, fuller life. Users can shower, sleep, and swim with the device in the ear. This device overcomes the "hollow sound" associated with previous devices and does away with daily cleaning and frequent battery changes.

The InSound XT is custom-fitted and then inserted deep into the canal by an otolaryngologist, in collaboration with an audiologist, in a 3-minute, nonsurgical procedure requiring no anesthesia. It is placed close to the eardrum, improving upon the current standard of sound quality by increasing high-frequency amplification and minimizing feedback. Upon battery depletion, a new device is inserted and the old device is discarded.

The InSound XT solves the extended-wear challenge through micro-miniaturization and an ultra-low power chip, which requires less than 10% of the energy of conventional hearing aids, extending the lifespan of the battery to up to 4 months. Clinical studies are ongoing at the University of California, San Francisco and at InSound Medical. The San Francisco Bay area will be the first test market for the InSound XT in 2003.

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