Sonitus Medical Inc, San Mateo, Calif, a medical device company developing a nonsurgical and removable hearing device to transmit sound via the teeth reports the publication of the first peer reviewed article on its SoundBite hearing system. The article titled "Preliminary Evaluation of a Novel Bone-Conduction Device for Single-Sided Deafness" is published in the most recent issue (31:492-497, 2010) of the Otology & Neurotology professional journal.
"The data presented in this initial publication shaped the development of our nonsurgical bone conduction device," said Amir Abolfathi, CEO of Sonitus Medical, in a statement. "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."
Gerald R. Popelka, PhD, professor of otolaryngology and chief of the Division of Audiology at the Stanford University School of Medicine, Palo Alto, Calif, is the article’s lead author. Popelka, who serves on the company’s scientific advisory board, and his coauthors, reported on key measurements of the hearing system related to oral function and oral health, calibration, auditory performance, speech intelligibility, and overall comfort.
According to a statement released by the company, following a review of existing treatment approaches for SSD, Popelka 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 (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).
The SoundBite hearing system is a nonsurgical 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, according to the company. The system employs bone conduction to deliver clear, high-quality sound to the inner ear, the company adds. It consists of a user-friendly 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.
Sonitus Medical Inc. is a privately held medical device company. The system’s hearing and communication platform is currently for investigational use only and is initially intended as a simple, noninvasive 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.
[Source: Sonitus Medical]