Ovesen T, Johansen LV Post-operative problems and complications in 313 consecutive cochlear implantations. J Laryngol Otol. 2009 May;123(5):492-6. doi: 10.1017/S0022215108003691. Epub 2008 Oct 10.
Richard C, Fayad JN, Doherty J, Linthicum FH Jr Round window versus cochleostomy technique in cochlear implantation: histologic findings. Otol Neurotol. 2012 Sep;33(7):1181-7. doi: 10.1097/MAO.0b013e318263d56d.
Sun CH, Hsu CJ, Chen PR, Wu HP Residual hearing preservation after cochlear implantation via round window or cochleostomy approach. Laryngoscope. 2015 Jul;125(7):1715-9. doi: 10.1002/lary.25122. Epub 2015 Jan 13.
Todt I, Basta D, Ernst A Does the surgical approach in cochlear implantation influence the occurrence of postoperative vertigo? Otolaryngol Head Neck Surg. 2008 Jan;138(1):8-12. doi: 10.1016/j.otohns.2007.09.003.
Wanscher JH, Faber CE, Grøntved AM [Cochlear implantation in deaf adults: effect on quality of life]. Ugeskr Laeger. 2006 Aug 14;168(33):2656-9. Danish.
Zawawi F, Alobaid F, Leroux T, Zeitouni AG Patients reported outcome post-cochlear implantation: how severe is their dizziness? J Otolaryngol Head Neck Surg. 2014 Dec 10;43:49. doi: 10.1186/s40463-014-0049-z. eCollection 2014.
Vestibular Function Evaluated by the Video Head Impulse Test (vHIT) and Vertigo Perceived by the Patients Before and After Cochlear Implant Surgery.
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.
