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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 uses the tooth instead of the implanted component and eliminates the need for surgery. It is therefore typically lower in complications and in cost than the prevalent surgical treatments. 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, and wirelessly transmits the sound signals to the ITM device. The ITM receives these signals and converts them into sound vibrations. These subtle sound vibrations travel via the teeth, through bones in the skull, to the functioning inner ear or cochlea, bypassing problems in the outer or middle ear entirely. Although the vibrations are strong enough to be picked up by the cochlea, they are so subtle as to not be felt by 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,〔http://www.hearingreview.com/2015/02/sonitus-medical-holds-auction-closing-doors/〕 as a result of the US Centers for Medicare & Medicaid Services' decision not to cover the device.〔http://www.mddionline.com/blog/devicetalk/cms-coverage-decision-killed-my-80m-venture-backed-startup-04-02-15〕 ==History== Single-sided deafness (SSD) and conductive hearing loss (CHL) are life-altering conditions where patients often have anxiety, depression, social isolation, and reduced quality of life.〔(【引用サイトリンク】url=http://www.hearinglosseducation.com/Hearing/who-has-hearing-loss.asp )〕 SSD patients have one cochlea that is virtually non-functional. It does not hear sound even when using conventional hearing aids, which are amplification devices that simply “turn up the volume” on air-conducted sound. CHL patients have a problem with the ear (outer, middle or canal) that prohibits air conducted sound from reaching an otherwise functional cochlea. Conventional hearing aids which amplify sound can cause distortion for these patients. Therefore, the traditional treatment approach has been a prosthetic device called Baha, which replaces the function of the impaired ear by using a well-established principle called bone conduction to re-route sound through the skull bones to the functional cochlea. The Baha bone conduction prosthetic devices are used rather than hearing aids because conventional hearing aids are clinically inappropriate for these patients. The Baha surgery can cause complications that range from skin reaction to infection, to abscess, to complete re-implantation or revision of the Baha post.〔(【引用サイトリンク】url=http://www.cms.gov/manuals/downloads/bp102c16.pdf )〕 In the United States, the Medicare Benefit Policy Manual distinguishes between hearing aids and prosthetic devices, and indicates that certain devices (including Baha) are payable by Medicare as prosthetic devices when hearing aids are medically inappropriate. The principle of bone conduction has been used for many years to treat patients with single-sided deafness and conductive hearing loss. The principle is based on decades of research showing that bone conduction stimulation of the teeth initiates auditory sensations. Evidence shows that teeth vibrations lead to audio-frequency vibration transmissions via soft tissue. Those transmissions then travel through skull foramina into the skull cavity. From there, they channel into the inner ear fluids, stimulating the cochlea. Subsequently, Sonitus Medical developed SoundBite Hearing System to use those principles in a non-surgical, removable hearing system. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「SoundBite Hearing System」の詳細全文を読む スポンサード リンク
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