PROJECT DESCRIPTION Thrive Neuromedical LLC proposes to develop, test, and gain FDA clearance to market a therapeutic device to improve speech sound differentiation in preterm infants hospitalized in the neonatal intensive care unit (NICU). During this project we will complete development of the smallTalk NICU Active system and conduct a clinical trial to prove its efficacy in improving speech sound differentiation among hospitalized preterm infants. The device is designed to be used at an age equivalent to 32 weeks of gestation or older and to integrate readily into clinical practice for use by nurses and therapists staffing Level II to Level IV NICUs. Prototype research and development met or exceeded the stated technical milestones. In 2020, preterm birth affected 1 of every 10 infants born in the United States. Large numbers of infants are born daily requiring NICU stays. This NICU stay, while medically necessary, can result in impairments in the developing infant brain. In particular, there is a lack of exposure to infant directed parental or caretaker voice. It is known that exposure to infant directed speech, which is different from adult directed speech, is developmentally important for optimal, early brain development. The ability to differentiate speech sounds is a prerequisite for developing more complex receptive language. Infant directed speech, ideally when sought by an attentive infant, stimulates brain wiring and attunes the infant’s brain to speech sounds. For the developing infant brain, “plasticity” for language learning peaks during infancy, as the baby develops neural connections that enable differentiating their native language’s speech sounds. These connections are the foundation for more complex brain functions. Due in part to their time in NICU care, preterm infants have poorer receptive language scores at age two. A majority require speech and language intervention prior to school age. There is currently no intervention that addresses the problem of poor speech sound differentiation arising from NICU hospitalization, a period when the greatest potential for improving outcomes exists. This proposal seeks funding for the final product development and rigorous testing of the smallTalk NICU Active system. We will manufacture a small batch of the devices to support a proposed randomized clinical study at Emory University, the results of which will be submitted to FDA for clearance to market the innovative device.