BackgroundHearing protection for neonates that can be effectively used during magnetic resonance imaging (MRI) examinations is limited. Because MRI-related acoustic noise poses a serious risk to this patient population, a viable option for hearing protection is needed. A new hearing protector device was recently developed specifically for neonates. Because of safety concerns for products used in the MRI setting, the objective of this investigation was to evaluate MRI-related issues for this hearing protector device. In addition, patient tolerance and responses were observed and reported from in a small group of neonates. MethodsThe neonatal hearing protector device (DREAMIES T-M, NEATCap Medical, LLC, Bethlehem, Pennsylvania) was evaluated for magnetic field interactions (translational attraction and torque; 3-Tesla), MRI-related heating (1.5-Tesla/64-MHz and 3-Tesla/128-MHz), and in vitro testing of artifacts (T1-weighed spin echo and gradient echo pulse sequences obtained at 3-Tesla) using standardized test procedures. In addition, seven study subjects wearing the neonatal hearing protector device underwent MRI of the brain. ResultsThere was no translation attraction, no torque, no heating at 1.5-Tesla/64-MHz and 3-Tesla/128-MHz, and no artifacts were observed for the neonatal hearing protector device in the in vitro and study subject observations. The device was easy to apply, stayed in place for the duration of the MRI examination, and was tolerated well by the neonates evaluated. ConclusionsBecause of the benign findings for the MRI tests, along with the materials used to make this device (i.e., nonmetallic and nonconducting), this new neonatal hearing protector device is designated “MR Safe”, which is a medical device that poses no known hazards resulting from exposure to any MRI environment. In the limited number of subjects evaluated during the observational period, the device provided sufficient noise protection enabling neonates to remain undisturbed throughout their scans, resulting in images with little or no motion artifacts and diagnostically acceptable MRI examinations.