SoundBite™ Hearing System
SoundBite™ Hearing System is an innovative new approach to treating patients with Single Sided Deafness (SSD), a loss of hearing in one ear. SoundBite is the world’s first removable and non-surgical hearing solution to use the well-established principle of bone conduction to imperceptibly transmit sound via the teeth to the inner ears. It is designed to help people regain their spatial hearing ability and rejoin the conversation of life.
SoundBite uses bone conduction to deliver clear, high quality sound to the inner ear. Many familiar sounds are heard through bone conduction; for example chattering your teeth, crunching on potato chips, or scratching your scalp. Nearly invisible when worn, the SoundBite system consists of an easy to insert and remove in-the-mouth (ITM) hearing device and a small microphone unit worn behind the ear (BTE). The device is currently cleared by the FDA to treat Single Sided Deafness.
What Makes SoundBite Different?
Sound to our ears travels through either air or bone/teeth. SoundBite uses bone conduction via the teeth to transmit sound to the cochlea, the auditory part of the inner ear. Unlike bone-anchored surgical hearing aids that entail invasive permanent implants in the skull, SoundBite is an advanced hearing solution that offers several important advantages:
- Clinically proven efficacy. A multi-center clinical study conducted in 2011 validated that the device is safe, effective, and provides a substantial benefit for Single Sided Deafness patients. In particular, study results demonstrated that SoundBite improved hearing and the ability to understand speech, even in noisy environments.
- No surgery required. SoundBite is simple, removable, and totally non-invasive. No dental alterations to teeth are required.
- Virtually invisible. SoundBite cannot easily be seen while being worn.
- Comfort and ease of use. SoundBite is custom made for each patient, ensuring a proper and comfortable fit. Patients can continue to eat, drink, and bite down safely.
How Does SoundBite Work?
SoundBite Hearing System consists of two components:
- An in-the-mouth (ITM) hearing device, which is custom made to fit around the upper, left or right, back teeth
- A small behind-the-ear (BTE) microphone unit worn on the impaired ear.
The outer ear has natural acoustic benefits as it collects and channels sound from the environment into the ear canal. To take advantage of this, a tiny microphone is placed within the canal of the impaired ear and is connected by a nearly invisible tube to the BTE unit. The BTE transmits the sound signals to the ITM, which converts them into imperceptible sound vibrations that travel through the teeth and jawbone to the cochlea, nearly simultaneously. Therefore, sound is re-routed directly to the cochlea – bypassing the middle and outer ear entirely – to restore the perception of hearing in the impaired ear.
Who Is a Candidate for SoundBite?
SoundBite is appropriate for patients 18 years or older who suffer from moderately severe, severe, or profound sensorineural hearing l oss in one ear and have normal hearing in the other ear. A SoundBite trained hearing professional, typically an Ears, Nose and Throat doctor (also known as an ENT, otolaryngologist, or otologist), will evaluate a patient’s hearing and determine if SoundBite is a viable solution. The system is intended for patients with sound oral health and tooth structures.
Clinical Safety and Efficacy
In two pivotal clinical trials, which supported the FDA clearance, SoundBite was proven safe and effective. One study evaluated the SoundBite system over a period of one month in 28 patients. Results of this study have been published in the well-respected Otology and Neurotology professional journal. A second study evaluated the long-term safety of the device over a six month period in 22 patients.
The studies evaluated the SoundBite system’s impact on auditory performance, improvement in speech intelligibility, oral health and overall comfort. Findings included:
- 95% of patients were either satisfied or very satisfied with the performance of the SoundBite device in terms of addressing their hearing problem after six months of wear, and 95% were also either likely or very likely to recommend the device to a friend who had the same hearing problem.
- The device was found to be safe for long-term use. No medical, dental, or audiological product- or procedure-related adverse events were reported after six months of wearing the SoundBite system.
Who Stands Behind SoundBite
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 device is a simple and non-invasive hearing and communication platform that is currently FDA cleared for the treatment of single sided deafness. Intended future applications include indications for hearing disorders such as mixed hearing loss and tinnitus, as well as 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
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