Sonitus Medical, a medical device company developing non-surgical and removable hearing device to transmit sound via the teeth, has reported the publication of the first peer reviewed article on its SoundBite hearing system.
The article, entitled ‘Preliminary Evaluation of a Novel Bone-Conduction Device for Single-Sided Deafness,’ was published in the most recent issue of the Otology & Neurotology professional journal.
Gerald Popelka, lead author of the article and professor of Otolaryngology noted that his team’s evaluations of the new device showed: A very wide frequency bandwidth that was confirmed to be adequate for reproducing speech and improving speech intelligibility in noise; 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.
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.
SoundBite hearing system is the 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 in-the-mouth (ITM) 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.
The 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.
Amir Abolfathi, CEO of Sonitus Medical, said: “The data presented in this initial publication shaped the development of our non-surgical bone conduction device. 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.”