To determine the efficacy, benefit, and safety of a new in-the-mouth bone conduction device (SoundBite Hearing System) for single-sided deafness (SSD).
A multicenter, controlled, nonrandomized prospective unblinded study of SSD patients wearing the device.
Ambulatory care centers typical of those where SSD patients are diagnosed and treated.
Adults (ages >18 and <80 yr) with acquired, permanent SSD (N = 28) and no current use of any SSD device.
Continual daily wear of the new device over a 30-day trial period.
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.
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.
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.