In the United States, the device has FDA clearance to treat patients with single-sided deafness (SSD) or conductive hearing loss (CHL).
The company filed for bankruptcy on Thursday, January 15, 2015,[1] as a result of the US Centres for Medicare & Medicaid Services' decision not to cover the device.
[2] Single-sided deafness (SSD) and conductive hearing loss (CHL) are life-altering conditions where patients often have anxiety, depression, social isolation, and reduced quality of life.
CHL patients have a problem with the ear (outer, middle or canal) that prohibits air conducted sound from reaching an otherwise functional cochlea.
A multi-centre clinical trial conducted in 2011 validated that SoundBite is safe and effective and provides substantial benefit for individuals with single-sided deafness (SSD).
Based on the clinical trial results, SoundBite improves the ability of individuals with SSD to understand speech in an environment with background noise by an average of 25%.
The results of this extensive clinical trial showed SoundBite to be as effective as surgically implanted bone conduction systems in improving the ability to understand speech in an environment with background noise.
Results from the APHAB questionnaire showed patients had significant improvement in Ease of Communication, Reverberation, Background Noise, and Global Benefit.
Additionally, the patient survey showed strong satisfaction with the device: 100% would recommend SoundBite to a friend or family member with similar hearing loss.
SoundBite uses the same mechanism of action as Baha devices (bone conduction), however it places a transducer on the tooth —a "naturally Osseo integrated" post—and thereby eliminates the need for a surgical implant.
A dentist then performs a dental screening and takes a partial impression of the patient's teeth, which is used to create a customized SoundBite ITM device.