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.
*Camino Ear Nose and Throat, San Jose; †Department of Otolaryngology-Head and Neck Surgery, Stanford University, Stanford; and ‡Ross Miller Orthodontics, Sunnyvale, California, U.S.A.
Address correspondence and reprint requests to Gerald R. Popelka, Ph.D., Department of Otolaryngology-Head and Neck Surgery, Stanford University, Stanford, CA; E-mail: email@example.com
Sources of Support: Sonitus Medical, Inc., provided the devices, patient medical and related expenses, professional fees (M. M. and R. M.), and data analysis fees (G. R. P.).
Potential Conflicts of Interest: The authors are not employees of Sonitus Medical, Inc., but have these relationships: Dr. Murray owns stock options and provides consulting to Sonitus Medical, Inc.; Dr. Popelka provides consulting to Sonitus Medical, Inc.; and Dr. Miller owns stock and stock options and provides consulting to Sonitus Medical, Inc.