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"The data presented in this initial publication shaped the development of our non-surgical bone conduction device," said Amir Abolfathi, CEO of Sonitus Medical. "It laid the groundwork necessary to complete our SoundBite hearing system, which has since been investigated in a clinical trial whose findings have been submitted to the FDA. As part of our sustained commitment to generate good clinical data, we look forward to sharing our clinical trial results in a future publication."
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Lead author of the article was Gerald R. Popelka, Ph.D., Professor of Otolaryngology and Chief of the Division of Audiology at the Stanford University School of Medicine. Dr. Popelka, who serves on the company's Scientific Advisory Board, and his co-authors, reported on key measurements of the hearing system related to oral function and oral health, calibration, auditory performance, speech intelligibility, and overall comfort.
Following a review of existing treatment approaches for SSD, Dr. Popelka noted that his team's
evaluations of the new device showed:
About SoundBite
SoundBite hearing system is the world's first and only non-surgical and removable hearing solution designed to imperceptibly transmit sound via the teeth to help people who are essentially deaf in one ear regain their spatial hearing ability and rejoin the conversation of life. It employs a well-established principle called bone conduction to deliver clear, high quality sound to the inner ear. Nearly invisible when worn, the SoundBite system consists of an easy to insert and remove ITM (in-the-mouth) hearing device -- which is custom made to fit around either the upper left or right back teeth -- and a small microphone unit worn behind the ear. No modifications to the teeth are required. This system is currently for investigational use only with a pivotal clinical trial now complete as intended to support an initial filing for FDA 510(k) clearance to treat single sided deafness. Intended future indications include conductive and mixed hearing loss.
About Sonitus Medical
Sonitus Medical Inc. is a privately held medical device company developing the SoundBite hearing system, a non-surgical and removable hearing solution that imperceptibly transmits sound via the teeth. Relying on the principle of bone conduction, this nearly invisible ITM (in-the-mouth) hearing and communication platform is currently for investigational use only and is initially intended as a simple and non-invasive treatment for hearing disorders such as single sided deafness, conductive and/or mixed hearing loss and tinnitus. Potential future applications include consumer and covert communications. Founded in June 2006, Sonitus Medical is headquartered in San Mateo, California. To learn more about Sonitus Medical, please visit www.sonitusmedical.com.
-- A very wide frequency bandwidth that was confirmed to be adequate for reproducing speech (n=12) and improving speech intelligibility in noise (n=5 SSD subjects); -- No detrimental effects on oral function or oral health of the teeth, and no evidence of wear to the tooth surface after 1.5 years of simulated use (n=4). In fact, forces applied by the device were found to be several orders of magnitude lower than an electric toothbrush; and -- High satisfaction with the physical comfort of the device as it was rated equal to or better than both behind-the-ear and in-the-ear hearing aid devices in terms of overall comfort, ease of insertion and removal, and visibility (n=12).
SOURCE Sonitus Medical, Inc.
