This article is about the hearing aid. For other uses, see Sound bite.
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SoundBite Hearing System is a non-surgical bone conduction prosthetic device that transmits sound via the teeth. It is an alternative to surgical bone conduction prosthetic devices, which require surgical implantation into the skull to conduct sound.
SoundBite avoids surgery by using the teeth rather than the implanted component. As a result, it is frequently less expensive and less complicated than the common surgical procedures.
SoundBite Hearing System has two principal components: a behind-the-ear (BTE) microphone unit that is worn on the impaired ear and a removable, custom-made in-the-mouth (ITM) device worn on the upper, left or right back teeth. Both components have rechargeable batteries and a charger is included with the system.
The BTE microphone captures and processes sound, wirelessly transmitting signals to the ITM device. The ITM converts these signals into subtle sound vibrations, which travel through the teeth and skull bones to reach the functioning inner ear, bypassing potential outer or middle ear complications. The vibrations are strong enough to be detected by the cochlea but remain imperceptible to the wearer.
In the United States, the device has FDA clearance to treat patients with single-sided deafness (SSD) or conductive hearing loss (CHL). SoundBite also has CE mark approval for SSD, CHL, and mixed hearing loss (MHL).
SoundBite was developed and marketed by Sonitus Medical, Inc. The company filed for bankruptcy on Thursday, January 15, 2015,[1] as a result of the US Centers for Medicare & Medicaid Services' decision not to cover the device.[2]
^"Sonitus Medical to Hold Auction After Closing Its Doors". 2015-02-10.
^"CMS Killed My $80M Venture-Backed Startup | MDDI Medical Device and Diagnostic Industry News Products and Suppliers". mddionline. Archived from the original on 2015-04-07.
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