title: A novel intraoral bone conduction hearing prosthesis: one-year safety and efficacy study.
abstract: OBJECTIVE
  To assess the safety and efficacy of an intraoral bone conduction (IOBC) hearing prosthesis after 12 months of use.
  
  
  METHODS
  Prospective cohort study.
  
  
  METHODS
  Multisite study including private practice, hospital-based practice, tertiary care, and academic medical centers.
  
  
  METHODS
  Patients aged 18 years or older with single-sided deafness (SSD).
  
  
  METHODS
  At the end of 6 months and 12 months, patients were asked to complete the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire and SSD questionnaire in addition to audiometric testing.
  
  
  RESULTS
  Eighty-one patients completed the study. Hearing thresholds remained the same throughout the study. APHAB results showed a significant benefit (p < 0.001) in categories of ease of communication, reverberation, background noise, and global score. The SSD questionnaire showed a high satisfaction among participants, with 93.8% of patients likely to recommend the IOBC. Dissatisfaction was highest with regard to patient's ability to eat with device, with only 55.6% satisfied. No serious adverse events were reported during the study.
  
  
  CONCLUSIONS
  The IOBC is a safe and effective alternative to percutaneous osseointegrated hearing implants for patients with SSD. Patient satisfaction and improved hearing benefit are observed after 1 year of using the device. The IOBC significantly benefitted patients in APHAB categories of ease of communication, reverberation, background noise, and the overall global hearing score. The in-the-mouth transducer is the least-liked feature for some patients, particularly with regard to eating; however, the majority of patients are willing to deal with the size of the device for the hearing benefit gained.
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: Stuart H
authors.initials: SH
authors.lastname: Curtis
authors.forename: Clough
authors.initials: C
authors.lastname: Shelton
mesh_terms: D000368:Aged; D001299:Audiometry; D001844:Bone Conduction; D015331:Cohort Studies; D005260:Female; D006310:Hearing Aids / Q000009:adverse effects; D046088:Hearing Loss, Unilateral / Q000209:etiology / Q000628:therapy*; D006320:Hearing Tests; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D019919:Prosthesis Implantation; D011795:Surveys and Questionnaires; D016896:Treatment Outcome