San Mateo, California (PRWEB) October 21, 2011
Sonitus Medical (http://www.sonitusmedical.com/), a privately held medical device company, has created the world’s first non-surgical and removable hearing prosthetic to transmit sound via the teeth. The SoundBite Hearing System is now FDA cleared for the treatment of single sided deafness and conductive hearing loss.
Hearing loss is an isolating condition that can make life’s simple tasks very difficult. Single sided deafness, also known as sudden hearing loss, is a type of hearing loss where there is significant or total hearing loss in one ear, while the good ear has hearing within normal limits. Today, by some estimates, there are over nine million Americans who suffer from the condition, which is caused by a problem in the inner ear or cochlea. Conductive hearing loss is caused by a problem in the outer or middle ear, when sound cannot efficiently travel from the outer ear canal to the eardrum and tiny bones of the middle ear. Both conditions can severely impact quality of life for patients.
SoundBite Hearing System works by making innovative use of the well-established, natural principle that hearing professionals call bone conduction – the transmission of imperceptible sound vibrations through bones to the inner ears. Nearly invisible when worn, SoundBite Hearing System consists of two components. The first is an easy to insert and remove in-the-mouth hearing device that is custom made to fit around the upper, left or right back teeth. The second is a small behind-the-ear microphone unit worn on the impaired ear. Sound waves from the outer ear are picked up from this microphone unit, digitally processed, and sent to the in-the-mouth hearing device. Here, they are converted to imperceptible sound vibrations that travel via the teeth, through bone, to the cochlea. In this way, sound is re-routed from the impaired ear directly to the good cochlea. Sound bypasses the middle and outer ear entirely to effectively restore the perception of hearing from the impaired ear.
SoundBite received FDA clearance for the treatment of single sided deafness in January of 2011. Principal Investigator for the studies was Michael Murray, M.D., an Otologist with Camino Ear Nose and Throat of San Jose, CA. "My patients were extremely happy with the SoundBite system in terms of how well it addressed their hearing problem without requiring them to undergo an invasive surgery," said Dr. Murray. "This new approach gives me a great new treatment option for my patients. Until now, these patients have chosen to go untreated due to the lack of an acceptable alternative."
In July 2011, SoundBite received its second FDA clearance for the treatment of conductive hearing loss. "We are pleased that the uses of the SoundBite system continue to expand," said Amir Abolfathi, CEO of Sonitus Medical. "As we begin the roll out of our product in partnership with otologists, ENTs, and audiologists, we remain committed to increasing the number of patients who may benefit from our non-surgical treatment option."
The SoundBite hearing system is available now through physicians and audiologists in a few select markets in the US (see where at http://www.soundbitehearing.com/find/), with planned expansion to additional markets nationwide over the following several months.
Sonitus Medical (http://www.sonitusmedical.com) is a privately held medical device company committed to providing advanced hearing solutions that hearing professionals such as otologists, ENTs, and audiologists can use to help their patients rejoin the conversation of life. Founded in June 2006, the company is headquartered in San Mateo, California. Its SoundBite Hearing System is the world′s first non-surgical and removable hearing solution that relies on bone conduction to imperceptibly transmit sound via the teeth. Currently FDA cleared for the treatment of both single sided deafness and conductive hearing loss, SoundBite Hearing System has intended future indications for hearing disorders such as mixed hearing loss and tinnitus, as well as consumer and covert communications. Additionally, the company has received its CE Mark certification, which indicates Full Quality Assurance System Approval and that Sonitus Medical's design and manufacturing processes for the SoundBite system comply with certain manufacturing and design standards under the European directive concerning medical devices.