Objective: To evaluate the performance of smartphone-based hearing screening with the hearScreen (TM) application in terms of sensitivity, specificity, referral rates, and time efficiency at two primary health care clinics. Design: Nonprobability purposive sampling was used at both clinics. A total of 1236 participants (mean age: 37.8 +/- SD 17.9 and range 3 to 97 years; 71.3% female) were included in the final analysis. Participants were screened using the hearScreen (TM) application following a two-step screening protocol and diagnostic pure-tone audiometry to confirm hearing status. Results: Sensitivity and specificity for smartphone screening was 81.7 and 83.1%, respectively, with a positive and negative predictive value of 87.6 and 75.6%, respectively. Sex [chi(2)(1, N = 126) = 0.304, p >0.05] and race [chi(2)(1, N = 126) = 0.169, p >0.05)] had no significant effect on screening outcome for children while for adults age (p < 0.01; beta = 0.04) and sex (p = 0.02; beta = -0.53) had a significant effect on screening outcomes with males more likely to fail. Overall referral rate across clinics was 17.5%. Initial screening test times were less than a minute (48.8 seconds +/- 20.8 SD) for adults and slightly more than a minute for children (73.9 seconds +/- 44.5 SD). Conclusions: The hearScreen (TM) smartphone application provides time-efficient identification of hearing loss with adequate sensitivity and specificity for accurate testing at primary health care settings.