title: Safety of an intra-oral hearing device utilizing a split-mouth research design.
abstract: OBJECTIVE
  The auditory deficits of Single Sided Deafness (SSD) can be treated effectively with a novel device, SoundBite, that delivers sound by applying imperceptible vibratory signals to the teeth (hereafter referred to as an intra-oral hearing device). The intra-oral hearing device is placed around two maxillary teeth and is similar to a small partial denture or retainer. The goal of this study was to report how this removable hearing device affects the oral structures.
  
  
  METHODS
  Twenty-two SSD patients wearing an intra-oral hearing device were enrolled in a prospective study for six months. Differences (delta) between the device-anchoring teeth and the equivalent contralateral non-device teeth were evaluated with four dental parameters using a paired t-test. Hearing thresholds were evaluated as a function of alveolar bone support using linear regression.
  
  
  RESULTS
  Compared to the non-device teeth, the hearing device teeth did not exhibit any increased recession (delta = 0.1 mm, p-value = 0.48), increased pocket depth (delta = 0.0 mm, p-value = 0.48), increased root resorption (delta = 4%, p-value = 0.43), or increased alveolar bone loss (delta = 0.0 %, p-value = 0.43). There was no association between the amount of alveolar support and hearing thresholds (delta = 0.2, p-value = 0.34).
  
  
  CONCLUSIONS
  The intra-oral component of the hearing device did not adversely affect the dental structures of the subjects in this trial.
authors.affiliation: rjmillerx@gmail.com
authors.forename: Ross
authors.initials: R
authors.lastname: Miller
authors.forename: Philippe
authors.initials: P
authors.lastname: Hujoel
authors.forename: Michael
authors.initials: M
authors.lastname: Murray
authors.forename: Gerald R
authors.initials: GR
authors.lastname: Popelka
mesh_terms: D000328:Adult; D000368:Aged; D016301:Alveolar Bone Loss / Q000145:classification / Q000000981:diagnostic imaging; D000539:Alveolar Process / Q000502:physiology; D001309:Auditory Threshold / Q000502:physiology; D001844:Bone Conduction / Q000502:physiology; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005889:Gingival Recession / Q000145:classification; D006310:Hearing Aids / Q000145:classification*; D046088:Hearing Loss, Unilateral / Q000534:rehabilitation; D006801:Humans; D007091:Image Processing, Computer-Assisted / Q000379:methods; D008297:Male; D008875:Middle Aged; D010512:Periodontal Index; D010514:Periodontal Pocket / Q000145:classification; D011446:Prospective Studies; D016300:Radiography, Bitewing / Q000379:methods; D012391:Root Resorption / Q000145:classification / Q000000981:diagnostic imaging; D014070:Tooth / Q000502:physiology; D014732:Vibration