ABSTRACT. Objectives. 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.Methods. 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 InfantToddler Meaningful Auditory Integration Scale and ageappropriate phoneme, and word and sentence recognition tests, when appropriate.Results. All children had full insertions of the electrode array without surgical complications and are developing age-appropriate auditory perception and oral language skills.Conclusions. 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. U niversal newborn hearing screening has allowed for the identification of severe to profound hearing loss at birth or within a few months thereafter. Because universal hearing screening programs have been and continue to be established throughout the United States, between 85% and 99% of newborns are being screened for hearing loss within 1 day of being born, with the remainder being tested within the first few months of life. This new population of hearing-impaired infants, who by virtue of the extent of their hearing losses are possible candidates for cochlear implantation, provides new opportunities and challenges.Research over time has demonstrated that the early identification of significant hearing loss followed by intervention procedures, including hearing aid usage commencing during the first 6 months of life, significantly increases the level of language development, speech intelligibility, and emotional stability as compared with children with later identification and intervention. 1-3 On average and over all degrees of hearing loss, children achieve higher levels in linguistic, academic, and social skills when management of hearing loss commences at an early age. Because much achievement in the world is based on linguistic competence, the ability of children to communicate often defines many aspects of their educational and social development. Consequently, the window of opportunity for language learning is critical to overall childhood development. For the most part, those critical years have been determined to be from birth to ϳ7 years of age, by which time the majority of th...