NCT03072862

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

Cochlear Implant and Healthy Aging: A Multinational, Multicentre Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	Commercial Nucleus Cochlear Implant Systems	Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality

Timeline

• Start date: 2017-11-06
• Primary completion: 2022-03-21
• Completion: 2022-03-21
• First posted: 2017-03-07
• Last updated: 2024-01-08
• Results posted: 2024-01-08

Locations

8 sites across 4 countries: France, Israel, Italy, Spain