Why it’s Breakthrough: It’s the world’s first and only non-surgical and removable hearing solution that imperceptibly transmits sound via the teeth to help people who are essentially deaf in one ear to rejoin the conversation of life.

The Story: A nearly invisible digital audio device called SoundBite™ relies on a well-established principle called bone conduction to deliver clear, high quality sound, and is intended to restore normal hearing functions to people with either single sided deafness, conductive, or mixed hearing loss. The SoundBite system consists of an easy to insert and remove dental retainer-like device which requires no modifications to your teeth, and a small microphone unit worn behind the ear. This device is for investigational use only and is currently slated for clinical trials that are intended to support an initial filing for FDA 510(k) clearance for single sided deafness.

The nearly invisible In The Mouth (ITM) hearing and communication platform relies on the principle of bone conduction, which has been well documented as a potentially viable way to aid those with single-sided hearing loss.

Following a review of existing treatment approaches for SSD, Gerald R. Popelka, Ph.D., Professor of Otolaryngology and Chief of the Division of Audiology at the Stanford University School of Medicine, who also serves on the company’s Scientific Advisory Board, and his co-authors, has studied and reported on key measurements of the hearing system related to oral function and oral health, calibration, auditory performance, speech intelligibility, and overall comfort. ”Both objective and subjective measurements from our study indicate that the new sound delivery system offers important potential benefits for a non-surgical treatment of single sided deafness,” Dr. Popelka said. “Based on the positive results and patient-perceived improvements, additional studies to investigate overall effectiveness and spatial hearing of this device are clearly warranted.”

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