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.