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

Cochlear

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Commercial Nucleus Cochlear Implant Systems

Study type: Observational

Funder types: Industry

Identifiers

NCT03072862

CEL5671

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Commercial Nucleus Cochlear Implant Systems

Treatment:

Device: Commercial Nucleus Cochlear Implant Systems