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

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Abstract

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.

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