Hearing Loss, Sensorineural — Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants
Citation(s)
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Kelly AS, Purdy SC, Thorne PR Electrophysiological and speech perception measures of auditory processing in experienced adult cochlear implant users. Clin Neurophysiol. 2005 Jun;116(6):1235-46. Epub 2005 Apr 26.
Kileny PR Use of electrophysiologic measures in the management of children with cochlear implants: brainstem, middle latency, and cognitive (P300) responses. Am J Otol. 1991;12 Suppl:37-42; discussion 43-7.
McPherson, D L. Late potentials of the auditory system. San Diego: Singular Publishing Group; 1996.
Okusa M, Shiraishi T, Kubo T, Nageishi Y Effects of discrimination difficulty on cognitive event-related brain potentials in patients with cochlear implants. Otolaryngol Head Neck Surg. 1999 Nov;121(5):610-5.
Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants
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.