title: The SoundBite hearing system: patient-assessed safety and benefit study.
abstract: OBJECTIVE
  To determine the safety and efficacy of the SoundBite for patients over a 6 month period of use.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Otolaryngology-Head and Neck Surgery, University of Utah, Salt Lake City, Utah, U.S.A.
authors.forename: Richard K
authors.initials: RK
authors.lastname: Gurgel
authors.forename: Clough
authors.initials: C
authors.lastname: Shelton
mesh_terms: D000328:Adult; D000368:Aged; D004867:Equipment Design; D005260:Female; D006310:Hearing Aids / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors; D055815:Young Adult
keywords: Baha; SoundBite; bone anchored hearing aid; single-sided deafness