The SoundBite hearing system: patient-assessed safety and benefit study.

OBJECTIVES/HYPOTHESIS: To determine the safety and efficacy of the SoundBite for patients over a 6 month period of use.

STUDY

DESIGN

Prospective, multisite, nonrandomized patient enrollment with outcomes based on audiometric profile and self-reported assessment.

METHODS

Patients with single-sided deafness were eligible for the study. Patients were fit with the standard SoundBite sound transducer and were asked to wear the device regularly for 6 months. At the end of the trial period, patients completed both a self-assessment and the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaires.

RESULTS

Thirty-four subjects completed the study. Mean APHAB scores improved significantly for ease of communication (P < 0.001), background noise (P < 0.001), reverberation (P < 0.001), and global benefit (P < 0.001). Patients reported high rates of auditory benefit in a variety of listening situations and high rates of overall satisfaction with the device. One adverse event with a superficial mouth sore was reported and resolved after appropriate dental care. Twelve patients (35%) reported acoustic feedback. In six of these patients, the feedback resolved after device adjustment.

CONCLUSION

The SoundBite is a new hearing prosthesis that delivers bone conduction energy. It offers advantages over traditional osseointegrated devices that require surgical placement. Patient satisfaction with the device after 6 months of regular use is high. The SoundBite provided improvement in ease of communication, hearing in background noise, sound reverberation, and an overall global hearing benefit. Acoustic feedback is the most commonly reported problem with the SoundBite, and this is minimized with proper fitting.