Universal hearing screening is essential for early identification of infants with hearing loss, yet there is a lack of low-cost, scalable equipment suitable for resource-constrained settings. Here we test a low-cost smartphone device for infant hearing screening. Infants aged 0 to 6months were recruited from 3 ambulatory clinics at Seattle Children's Hospital with a high prevalence of hearing loss. We compared results from a low-cost open-source distortion product otoacoustic emission (OAE) probe and smartphone app with results from a commercially available OAE device. Hearing status was confirmed using newborn hearing screening, diagnostic testing, or both. Primary outcomes were referral rate as well as sensitivity, specificity, positive predictive value, and negative predictive value compared with known hearing status. Among N = 76 infants, the mean age at screening was 3.1 ± 1.9months and 13% had hearing loss. Referral rates were 24% and 26% for the smartphone and conventional devices, respectively. Both devices demonstrated 100% sensitivity (95% CI, 0.69-1.00) and negative predictive value (95% CI, 0.94-1.00). Specificity was 88% (95% CI, 0.78-0.95) and 85% (95% CI, 0.74-0.92) for the smartphone and conventional devices, respectively. Positive predictive value was 56% (95% CI, 0.31-0.78) for the smartphone and 50% (95% CI, 0.27-0.73) for the conventional device. The smartphone-based OAE device effectively screened hearing in high-prevalence infants. Thus, smartphone-based OAE detection may be a promising low-cost solution to the challenge of building scalable universal newborn and infant hearing screening programs in resource-constrained settings.
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