As a result of universal newborn hearing screening and improved evaluation tools, many children with severe to profound hearing loss are being diagnosed as infants. This affords the opportunity to provide these children access to cochlear implantation, although medical and audiologic challenges must be addressed. The purpose of this study was to investigate the safety and efficacy of cochlear implantation in children who are younger than 1 year. A prospective study was conducted of 18 children who had confirmed severe to profound sensorineural hearing loss and received cochlear implants at our medical center before 12 months of age. The length of device usage ranged from 6 months to 4 years, 5 months. The main outcomes measured were perioperative and postoperative surgical/medical aspects, the Infant-Toddler Meaningful Auditory Integration Scale and age-appropriate phoneme, and word and sentence recognition tests, when appropriate. All children had full insertions of the electrode array without surgical complications and are developing age-appropriate auditory perception and oral language skills. Early implantation is feasible and beneficial in some children who are younger than 12 months and should be considered with attention to variables involved in the decision-making process, including possible increased surgical risk, skull size and scalp thickness, and mastoid development.