Hearing Loss
Conditions
Keywords
Cochlear implant treatment, aging adults
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.
Interventions
DEVICECommercial Nucleus Cochlear Implant Systems
Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality
Sponsors
Cochlear
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health Related Quality of Life Following Cochlear Implant Treatment | pre-implant surgery, 12 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 is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life. |
Countries
France, Israel, Italy, Spain
Participant flow
Recruitment details
100 participants were recruited in 8 centres from 06 November 2017 to 21 March 2022.
Participants by arm
| Arm | Count |
|---|---|
| Commercial Nucleus Cochlear Implant Systems Commercial Nucleus Cochlear Implant Systems: Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality | 98 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Commercial Nucleus Cochlear Implant Systems | — |
|---|---|---|
| Age, Continuous | 71.7 years STANDARD_DEVIATION 7.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 35 participants | — |
| Region of Enrollment Israel | 7 participants | — |
| Region of Enrollment Italy | 35 participants | — |
| Region of Enrollment Spain | 21 participants | — |
| Sex: Female, Male Female | 43 Participants | — |
| Sex: Female, Male Male | 55 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 100 |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 2 / 100 |
Outcome results
Primary
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
Population: Data were available for 85 participants for analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Commercial Nucleus Cochlear Implant Systems | Change in Health Related Quality of Life Following Cochlear Implant Treatment | Multi-attribute score | 0.14 units on a scale |
| Commercial Nucleus Cochlear Implant Systems | Change in Health Related Quality of Life Following Cochlear Implant Treatment | Hearing single-attribute | 0.22 units on a scale |
| Commercial Nucleus Cochlear Implant Systems | Change in Health Related Quality of Life Following Cochlear Implant Treatment | Speech single-attribute | 0.08 units on a scale |
Primary
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
Population: Data were available for 82 participants for analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Commercial Nucleus Cochlear Implant Systems | Change in Health Related Quality of Life Following Cochlear Implant Treatment | Multi-attribute | 0.13 units on a scale |
| Commercial Nucleus Cochlear Implant Systems | Change in Health Related Quality of Life Following Cochlear Implant Treatment | Hearing single-attribute | 0.25 units on a scale |
| Commercial Nucleus Cochlear Implant Systems | Change in Health Related Quality of Life Following Cochlear Implant Treatment | Speech single-attribute | 0.08 units on a scale |