Hearing Loss — Cochlear Implants in Young Children With SSD
Citation(s)
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Brown KD, Dillon MT, Park LR Benefits of Cochlear Implantation in Childhood Unilateral Hearing Loss (CUHL Trial). Laryngoscope. 2022 Mar;132 Suppl 6(Suppl 6):S1-S18. doi: 10.1002/lary.29853. Epub 2021 Sep 20.
Chweya CM, May MM, DeJong MD, Baas BS, Lohse CM, Driscoll CLW, Carlson ML Language and Audiological Outcomes Among Infants Implanted Before 9 and 12 Months of Age Versus Older Children: A Continuum of Benefit Associated With Cochlear Implantation at Successively Younger Ages. Otol Neurotol. 2021 Jun 1;42(5):686-693. doi: 10.1097/MAO.0000000000003011.
Corbin NE, Buss E, Leibold LJ Spatial Hearing and Functional Auditory Skills in Children With Unilateral Hearing Loss. J Speech Lang Hear Res. 2021 Nov 8;64(11):4495-4512. doi: 10.1044/2021_JSLHR-20-00081. Epub 2021 Oct 5.
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Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.