Chagrin Falls

Researchers are evaluating a new medical device designed to improve the ability of hospitalized preterm infants to differentiate speech sounds. This study focuses on infants born prematurely, specifically those at or beyond 32 weeks of gestational age, who often face risks of neurosensory impairments and developmental delays. The device aims to support infant learning by delivering the mother's voice contingent on the infant's sucking behavior, addressing the lack of natural parental speech exposure in neonatal intensive care units (NICUs). The intervention involves a disposable pacifier equipped with a sensor that measures suck pressure and timing. When the infant meets a calibrated suck threshold, the device triggers a NICU-safe speaker to play the mother's voice, providing an active and responsive auditory experience. The treatment period consists of 20 sessions over three weeks. The device is designed to integrate easily into NICU care and meets infection-control standards. Participants will undergo sensory processing assessments using EEG, with initial testing performed two days before starting the intervention and repeated within 24 hours after the last session. Researchers will measure brain responses to speech sounds to evaluate the effectiveness of the device. The study also considers environmental factors such as NICU room type and background noise. Overall, the study aims to objectively assess the device's impact on early speech sound processing in preterm infants during their NICU stay.

Researchers are evaluating the safety of daily disposable MiSight 1 Day soft contact lenses in children aged 8 to 12 years with myopia. This post-approval study aims to confirm the safety of these lenses in the intended US patient population. Safety data from a previous MiSight 1 Day study will also be used to supplement this evaluation. Participants will wear MiSight 1 Day lenses daily for three years. The study focuses on children interested in wearing contact lenses for about 10 hours per day, 6 days per week. During this time, subjects will be monitored to assess the incidence of microbial keratitis and other safety outcomes. Throughout the study, children will undergo regular eye exams to check visual acuity and eye health, ensuring they remain free from infections or complications. Parent or guardian consent and assent from the child will be obtained, and medical records will be reviewed to track outcomes related to contact lens safety over the three-year period.