Our objectives were 1) to determine whether transiently evoked otoacoustic emissions (TEOAEs) are affected by the status of the tympanic membrane (TM) and middle ear (ME) as determined by clinical examinations and tympanograms; 2) to determine the efficacy of TEOAEs in detecting hearing loss; and 3) to determine the relative effects of the ME status and hearing loss on TEOAEs. In a prospective observational study in a tertiary care children's hospital, 89 patients (169 ears; 9 ears eliminated from analyses) were examined by 2 attending pediatric otolaryngologists for otologic conditions and underwent audiologic evaluations including TEOAEs from August 1994 through May 1995. The main outcome measures were presence or absence of TEOAE whole reproducibility (WR) and reproducibility (R) at 2 kHz. Statistical analyses showed that of the 8 ME and TM conditions evaluated (normal, TM perforation, pressure equalization [PE] tube, TM retraction, tympanosclerosis, TM atrophy, ME effusion, surgery other than PE tube insertion), only the presence of ME effusion and normal examination findings had a significant effect on the results of WR and R at 2 kHz. Of the 6 different types of tympanograms evaluated (A, B, C, AD, As, B with large volume), type A, B, and C tympanograms had a significant effect on WR and types A and B had a significant effect on R at 2 kHz. Hearing losses > or = 25 dB hearing level (HL) at any of the 5 frequencies (0.25, 0.5, 1, 2, and 4 kHz) were well predicted by the absence of WR and R at 2 kHz. When clinical examination and impedance data were evaluated simultaneously with hearing status, hearing status had a greater effect on WR and R at 2 kHz. We conclude that type B and C tympanograms and the presence of ME effusion (which reflect abnormal ME status) have an adverse effect on TEOAEs. However, the presence of hearing loss is the most significant predictor of TEOAE results. The TEOAE WR and R at 2 kHz are effective in identifying patients with normal hearing and with hearing losses > or = 25 dB HL.