Identification of neonatal hearing impairment: A multicenter investigation

Objectives: This article describes the design of a multicenter study sponso red by the National Institutes of Health, The purpose of this study was to determine the accuracy of three measures of peripheral auditory system stat us (transient evoked otoacoustic emissions, distortion product otoacoustic emissions, and auditory brain stem responses) applied in the perinatal peri od for predicting behavioral hearing status at 8 to 12 mo corrected age. Th e influences of the infant's medical status, the test environment, and test and response parameters on test performance were examined. Design: Seven institutions participated in this study. There were 7179 infa nts evaluated in the perinatal period. All graduates of the neonatal intens ive care unit (4478) and well babies with one or more risk factor for heari ng loss (353) were targeted for follow-up testing using visual reinforcemen t audiometry (VRA) art 8 to 12 mo corrected age. Well babies without any ri sk indicators (N = 2348) were not targeted for follow-up VRA testing. Howev er, 80 of these well babies did not pass the screening protocol and thus we re targeted for follow-up VRA testing as well. Perinatal test performance w as evaluated using the VRA data as the "gold standard." Results: The results of this study are described in a series of II articles following this introductory article. Conclusions: The evaluation of newborn hearing tests required a longitudina l study in which newborn test results were compared with a gold standard ba sed on behavioral audiometric assessment. Such an evaluation was possible b ecause all newborns, passes as web as refers, were followed up long enough to permit reliable behavioral measurements. In addition, prenatal, perinata l, and maternal history information, test environment, and test parameter i nformation were collected to provide data that led to a complete descriptio n of factors affecting test outcomes. All of these data were obtained in a sample of sufficient ethnic, medical, and geographic diversity in efforts t o increase the generalizability of the results. Finally, the data were comb ined in a relational data base to examine the factors that influence test p erformance. Specific information related to these issues is presented in th e articles that follow.