Safety of an intra-oral hearing device utilizing a split-mouth research design.

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).

CONCLUSION: The intra-oral component of the hearing device did not adversely affect the dental structures of the subjects in this trial.