The purpose of this study is to show that cochlear implant treatment improves the overall health related quality of life and general well-being in elderly individuals.
The study is designed as an observational prospective repeated measures study with each subject acting as his/her own control. Subjects are evaluated subjectively at pre- and post-operative intervals that coincide with their routine visits to the clinic. Outcomes from routine practice and application of cochlear implant intervention are recorded through observational measures using clinical standards scales used widely in geriatrics and audiology. The study is aimed at collection of data for patients who have already made the decision together with their implant centre clinician for an implant device from the company Cochlear. Patients are approached for study participation prior to surgery by the caring clinician on a consecutive and voluntary basis and on condition of signing the patient informed consent.
Study Type
OBSERVATIONAL
Enrollment
100
Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality
Groupe Hospitalier de La Pitié Salpétrière
Paris, France
ENT Department-Hôpital Purpan
Toulouse, France
Bnai Zion Medical Center
Haifa, Israel
Rabin Medical Center (Beilinson)
Petah Tikva, Israel
Change in Health Related Quality of Life Following Cochlear Implant Treatment
Assessed via the Health Utilities Index Mark III (HUI 3) questionnaire. HUI-3 classification system consists of 8 attributes including vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. HUI-3 values range from -0.36 to 1.00. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change in scores is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Time frame: pre-implant surgery, 12 months post-surgery
Change in Health Related Quality of Life Following Cochlear Implant Treatment
Assessed via the Health Utilities Index Mark III (HUI 3) questionnaire. HUI-3 classification system consists of 8 attributes including vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. HUI-3 values range from -0.36 to 1.00. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change in scores will be presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Time frame: pre-implant surgery, 18 months post-surgery
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ENT Otosurgery Department-Azienda Ospedaliera di Padova
Padua, Italy
ENT Department Ospedale Guglielmo da Saliceto
Piacenza, Italy
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria, Spain
Clinica Universitaria de Navarra
Pamplona, Spain