Evaluation of the Benefits for Overall Health Following Cochlear Implant Treatment in the Elderly Population

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Unilateral CI candidates with bilateral post-lingual deafness with intention to treat
≥ 60 years at first unilateral cochlear implant
Implant ear: meets all local criteria for cochlear implant treatment
Contralateral ear: average pure tone thresholds indicate a moderately-severe to profound hearing loss (4 freq. average: 0.5, 1, 2 and 3 or 4 kHz > 56 dBHL).
Willingness to participate in and to comply with all study procedures
Fluency in languages used to assess clinical performance
Appropriate expectations from routine cochlear implant treatment
Able to decide on study participation personally and independently sign their consent

Exclusion Criteria

Significantly/severely dependent or fragile
Unable to provide consent personally
Unable to complete questionnaires for self-assessment independently
Unilateral hearing loss
Sequential and simultaneous bilateral cochlear implant recipients
Ossification or other cochlear anomalies preventing full electrode insertion
Retro cochlear or central origins of hearing impairment.
Significant comorbidities preventing study participation (e.g. blindness, immobility or in a wheel chair, severe aphasia)
Medical contraindications to surgery
Clinic Standard fail criteria for cochlear implant candidacy in regards to chronic depression, dementia, and cognitive disorders.
Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device.

Arm && Interventions

Group	Intervention	Description
Commercial Nucleus Cochlear Implant Systems	Commercial Nucleus Cochlear Implant Systems	-

Primary Outcome Measures

Name	Time	Method
Change in Health Related Quality of Life Following Cochlear Implant Treatment	pre-implant surgery, 18 months post-surgery	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.

Secondary Outcome Measures

Name	Time	Method

Locations (8): Bnai Zion Medical Center
🇮🇱
Haifa, Israel
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
Rabin Medical Center (Beilinson)
🇮🇱
Petah Tikva, Israel
Groupe Hospitalier de La Pitié Salpétrière
🇫🇷
Paris, France
ENT Department-Hôpital Purpan
🇫🇷
Toulouse, France
ENT Otosurgery Department-Azienda Ospedaliera di Padova
🇮🇹
Padova, Italy