Efficacy and Safety of an In-the-Mouth Bone Conduction Device for Single-Sided Deafness

OBJECTIVE: To determine the efficacy, benefit, and safety of a new in-the-mouth bone conduction device (SoundBite Hearing System) for single-sided deafness (SSD). STUDY DESIGN: A multicenter, controlled, nonrandomized prospective unblinded study of SSD patients wearing the device. SETTINGS: Ambulatory care centers typical of those where SSD patients are diagnosed and treated. PATIENTS: Adults (ages >18 and <80 yr) with acquired, permanent SSD (N=28) and no current use of any SSD device. INTERVENTION: Continual daily wear of the new device over a 30-day trial period. MAIN OUTCOME MEASURES: The Hearing in Noise Test (HINT), the Abbreviated Profile of Hearing Aid Benefit (APHAB), comprehensive pretrial and posttrial medical, audiologic, and dental examinations and an SSD questionnaire. RESULTS: The Hearing in Noise Test scores improved an average of -2.5 dB after 30 days, compared with wearing no device (p<0.001). The Abbreviated Profile of Hearing Aid Benefit scores improved (p<0.05) for all subjects for the Global and Background Noise subscales and for all but 1 subject for the Reverberation and Ease of Communication subscales. There were no medical, audiologic, or dental complications. CONCLUSION: The SoundBite system is safe and effective and provides substantial benefit for SSD patients with continual daily use over a 30-day period.