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ACEMg (Soundbites) is a neuroprotectant supplement designed to block the initiating biological events in the inner ear leading to inner ear hearing loss, sensorineural hearing loss, SNHL, which accounts for more than 90% of all hearing loss. SNHL is so common it is called hearing loss. There is no cure for SNHL. The 24-week OTIS Study aims to validate findings from the previous two-year real-world study demonstrating ACEMg (Soundbites) preserved or improved auditory function (hearing) for 75.3% of participants who used it daily, with most improvement occurring within six months. The study also aims to assess the potential of ACEMg to relieve tinnitus, hyperacusis, and hearing sensitivity symptoms. These symptoms are often correlated with SNHL; relief from tinnitus, hyperacusis and hearing sensitivity were were not measured in the previous two-year study. The OTIS study aims to answer two questions. First, does the real-world data demonstrate that hearing loss is stabilized or improved at the end of the test among participants with SNHL at the beginning? Second, do participants who self-report tinnitus, hyperacusis, or hearing sensitivity symptoms at the start of their test report reduced symptoms at the end? Participants must be eighteen years of age and older and self-report hearing loss and/or tinnitus. The study is conducted at home using a smartphone app and a web-based assessment and data reporting tool developed for this study. The study is conducted at home using an online hearing test and short surveys on tinnitus and hyperacusis. The tests are completed three times: Baseline tests are taken before participants begin to take ACEMg softgel capsules daily. The Test is repeated at about 11 and 24 weeks. Assessment scores at the beginning of the study will be compared with scores at the end. Participation in the study is free.
PROACTIVE NYS is a long-term follow-up study of all infants who test positive for congenital Cytomegalovirus infection (CMV) throughout New York State on the Newborn Screen. By following all infants who screen positive, we will learn important information about the range of symptoms caused by congenital CMV, from those babies with more severe findings to those with no symptoms. In particular, our study will provide new information about many facets of congenital CMV, including: * Developmental, hearing, neurologic, and vision outcomes * The spectrum and timing of symptoms * The impact congenital CMV has on the baby and its family * How many babies are infected with congenital CMV in New York State How antiviral medications and other interventions impact outcomes of children with congenital CMV Throughout the duration of the study, children will undergo routine developmental and hearing assessments, which will assist with early diagnosis of any infection complications. Any child found to have a neurodevelopmental, hearing, or vision abnormality will be referred for appropriate evaluation and treatment. Families will also be asked to complete periodic surveys about their experience with congenital CMV, both as a medical diagnosis and as it affects their day-to-day activities.
This is a retrospective and prospective longitudinal study in participants with Otoferlin Gene-Mediated Hearing Loss.