To determine whether late onset of canonical babbling could be used as a criterion to determine risk of hearing impairment, we obtained vocalization samples longitudinally from 94 infants with normal hearing and 37 infants with severe to profound hearing impairment. Parents were instructed to report the onset of canonical babbling (the production of well-formed syllables such as "da," "na," "bee," "yaya"). Verification that the infants were producing canonical syllables was collected in laboratory audio recordings. Infants with normal hearing produced canonical vocalizations before 11 months of age (range, 3 to 10 months; mode, 7 months); infants who were deaf failed to produce canonical syllables until 11 months of age or older, often well into the third year of life (range, 11 to 49 months; mode, 24 months). The correlation between age at onset of the canonical stage and age at auditory amplification was 0.68, indicating that early identification and fitting of hearing aids is of significant benefit to infants learning language. The fact that there is no overlap in the distribution of the onset of canonical babbling between infants with normal hearing and infants with hearing impairment means that the failure of otherwise healthy infants to produce canonical syllables before 11 months of age should be considered a serious risk factor for hearing impairment and, when observed, should result in immediate referral for audiologic evaluation.