SoundBite is a hearing aid technology that was developed by Sonitus Medical, a company specializing in single-sided deafness. Sonitus Medical received a second FDA clearance for the use of SoundBite for conductive hearing loss in early July, 2011, and released the product into the Washington market on July 18, 2011.
Bone Conduction Hearing Aid
A SoundBite unit consists of two separate parts: a behind-the-ear unit that receives the sound, and an inside-the-mouth unit that transmits the sound to the inner ear through the teeth and bones of the skull. According to Cochlear, bone conduction aids work better for some types of hearing loss, particularly for those patients who have damage to the outer or middle ear, or those who suffer from loss in a single ear. Bone conduction has been used in hearing implants for some time, but the SoundBite's non-surgical approach allows patients to try the technology without having invasive surgery.
Patient Trials
I was recently granted an interview with Amanda Mitchell, Director of Public Relations at DC Smiles to discuss the release of this new product. (DC Smiles is the office of Dr. Lawrence D. Singer, DMD, a partner dentist in the release of the SoundBite technology.) During the interview, I asked Ms. Mitchell about the patient trials. She had this to say in response:
"There were two investigative trials. One 30 days in length including 28 patients, and one 6 months in length with 22 patients. These safety and efficacy tests proved 100% successful and there were no adverse affects or negative results for anyone involved in the trials. All experienced well above the FDA's required (-1) improvement on the hint test (average from day 0-30 was a 25% improvement, or -2.5). After 6 months, this percentage of improvement remained stable in all cases."
Improving Hearing, A Bite at a Time
Although the implant device that is worn in the mouth looks awkward, a 2010 study published in the Ontology and Neurology journal finds that SoundBite "provides useful gain and output for SSD patients, is comfortable, does not seem to have detrimental effects on oral function or oral health, and has several advantages over existing devices." As with any new technology, the success of the in-mouth, no-surgery model will depend on whether or not it is embraced by consumers, but at this point the combination of FDA approval and positive scientific studies bode well for Sonitus Medical.
Sources:
- Cochlear. Bone Conduction Implants - Hearing Aid Bone Conductor. Accessed July 21, 2011.
- Mitchell, A. Phone Interview, July 20, 2011.
- Popelka G., Derebery J., Blevins N., Murray M., Moore B., Sweetow R., Wu B., Katsis M. Preliminary evaluation of a novel bone-conduction device for single-sided deafness. Otol Neurotol. 2010 Apr;31(3):492-7. Accessed July 21, 2011.
- Sonitus Medical, SoundBite in Detail. Accessed July 21, 2011.
Victoria Nicks - Victoria Nicks has a Master's Degree in IT, and extensive hands-on experience with various types of hardware and software.
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