Objective: To determine the long-term safety and benefit of a new intraoral bone conduction device (SoundBite Hearing System by Sonitus Medical) for single-sided deafness (SSD).
Study design: A multi-center, controlled, nonrandomized, prospective unblinded study of SSD patients wearing the device over a 6-month period.
Settings: Ambulatory care centers typical of those where SSD patients are diagnosed and treated.
Patients: Adults (N = 22) with acquired, permanent SSD and no current use of any other SSD device.
Intervention: Continual daily wear of the new device for 6 months.
Main outcome measures: Comprehensive medical, audiologic, and dental measures; aided thresholds; Abbreviated Profile of Hearing Aid Benefit scores, and an SSD questionnaire.
Results: There were no related adverse events or changes in the medical or audiologic findings at the end of the trial compared with the beginning. There were no significant changes in the mean aided thresholds (p > 0.01) or the mean dental measures (p > 0.05) at 3 or 6 months compared with pretrial measures. The mean Abbreviated Profile of Hearing Aid Benefit benefit scores showed improvement (p < 0.01) for the Background Noise, Reverberation, and Ease of Communication subscales and the Global scale at 3 and 6 months. The results of the SSD questionnaire indicated that the vast majority (>90%) of the subjects reported satisfaction and improvement in a variety of areas after wearing the device long term.
Conclusion: The SoundBite system is safe and continues to provide substantial benefit for SSD patients with continual daily use over a 6-month period.