Clinical & Scientific Information
Learn more about SoundBite™ by reading summaries of important publications by experts in the fields of otolaryngology, audiology, and dentistry. Our library of scientific and clinical information will provide you with a solid understanding of the benefits of SoundBite in treating single sided deafness.
Publications
1. "Long Term Safety and Benefit of a New Intraoral Device for Single Sided Deafness" (Otology & Neurotology: 2011): Currently in press – Available on-line soon
This article discusses positive findings from an important study designed to assess the long-term safety and benefit of the SoundBite Hearing System in singled sided deafness (SSD) patients, over a six month period. Results from this long term trial validate that SoundBite is safe: no medical, audiological, or dental safety issues were discovered during the six month trial period. Furthermore, the study confirmed that SoundBite provides substantial benefit for SSD subjects throughout the six month trial period. Specifically, SSD subjects wearing SoundBite experienced significant improvement in hearing, both overall and in the specific conditions in which they have difficulty: listening in background noise, reverberant environments and when communicating. Importantly, subjects also reported significant improvement in measures such as confidence and quality of life. Patients were highly satisfied with SoundBite, with 95% of patients reporting that they would recommend it to a friend who had single sided deafness. Because SoundBite Hearing System is safe for long term use, does not require surgery and provides effectiveness and benefit equivalent or superior to surgical solutions for SSD, it is a reasonable alternative to surgically-based SSD systems.
2. "Efficacy and Safety of an In-The-Mouth Bone Conduction Device for Single-Sided Deafness" (Otology & Neurotology: February 2011)
The article discusses the SoundBite multi-center clinical trial conducted in 2011, which validates that the device is safe, effective, and provides a substantial benefit for patients suffering from single sided deafness (SSD). Patients in the study wore SoundBite for a 30 day trial period, using the device an average of 8.2 hours per day. The study shows that SoundBite improves the ability of SSD patients to understand speech in noise by an average of 25% and for one third of the subjects, the improvement exceeds 30%. These results demonstrate that SoundBite is as effective in improving the ability to understand speech in noise as currently available surgical bone conduction treatments.
3. "SoundBite Hearing System by Sonitus Medical: A New Approach to Single-Sided Deafness" (Seminars in Hearing: December 2010)
Gerald Popelka, Ph.D., Department of Otolaryngology-Head Neck Surgery, Stanford University, provides an audiological perspective of SoundBite's novel approach to treating single sided deafness. The article explains the background and development of SoundBite and how it addresses limitations of existing devices for single sided deafness. The author summarizes results from a Hearing in Noise Test (HINT) performed with SSD patients using the new device, which indicate a substantial and immediate hearing improvement with SoundBite. Also discussed are research results which confirm SoundBite is safe on teeth, comfortable, and easy to insert and remove.
4. "It's Time We Listened To Our Teeth: The SoundBite Hearing System" (American Journal of Orthodontics & Dentofacial Orthopedics: November 2010)
The article introduces SoundBite Hearing System to dentists and orthodontists. Orthodontist Ross Miller, DDS, explains how SoundBite uses bone conduction to imperceptibly transmit sound via the teeth, to help patients with single sided deafness. The article summarizes the patient treatment process, and details what occurs during the patient's visit to the dentist.
5. "Safety of an Intra-Oral Hearing Device Utilizing a Split-Mouth Research Design" (The Journal of Clinical Dentistry: 2011)
This article presents positive safety findings from a study designed to assess the impact of SoundBite Hearing System on dental structures. The prospective, six month study of twenty-two single sided deafness patients concluded that there were no adverse effects associated with the wearing of the SoundBite intra-oral hearing device, anchored to two maxillary teeth. Compared to teeth on the side of the patient's mouth where no device was worn, the hearing device teeth did not exhibit any increased recession, pocket depth, root resorption, or alveolar bone loss. The intraoral hearing device had oral effects similar to commonly used removable dentures or retainers.
6. "Preliminary Evaluation of a Novel Bone-Conduction Device for Single-Sided Deafness" (Otology & Neurotology: October 2010)
Experts in the fields of otolaryngology, audiology, and dentistry provide a preliminary evaluation of the SoundBite hearing device. The article discusses the benefits of non-surgical bone conduction via the teeth for the treatment of single sided deafness. The authors highlight the significant improvement in auditory function gained by single sided deafness patients wearing the SoundBite device. Special notice is given to SoundBite's optimal microphone placement within the ear canal that improves spatial hearing and the ability to hear in noisy environments. Professionals also discuss the ability for SoundBite to provide a wider frequency bandwidth (up to 12,000 Hz), which is important for overcoming hearing deficits in SSD patients. Finally, the article highlights data that shows SoundBite is as comfortable as traditional hearing devices and is safe for tooth surfaces and oral health.
If you suffer from single sided deafness, SoundBite Hearing System may be the ideal choice for you. To learn more about SoundBite Hearing System visit Product Images or let us help you find a doctor in your area.
