Call for calibration standard for newborn screening using auditory brainstem responses.

The mode of stimulation employed in newborn screening of the auditory brainstem response has evolved from the clinically standardized supraaural earphone to the tubal insert earphone, to most recently a circumaural earphone developed for this test. Considered here is the need to develop a standard for calibration of such devices for newborn screening applications, in particular. At risk is the prospect of missing the milder degrees of hearing loss, assuming a goal of detecting all clinically-significant congenital hearing losses. Two commercially manufactured test instruments for automated newborn screening were scrutinized via bench testing of sound output from their respective transducers, using a variety of measurements. By convention or design, none of the measurement approaches involved a model of the newborn ear, per se. While it was concluded that the manufacturers' method shows promise, namely as a relatively simple and potentially reliable method of calibration, concerns arose regarding output levels when measured according to both the manufacturers' and the authors' methods. Further work is needed to critically assess calibration methods and to establish, to the extent possible, appropriate norms and validation studies in newborns to provide a better understanding of the actual sound pressure level of the screening stimulus.