N/A
N=100
Evaluation of the Benefits for Overall Health Following Cochlear Implant Treatment in the Elderly Population
Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT03072862 ↗Enrolled (actual)
100
Serious AEs
2.0%
Results posted
Jan 2024
Primary outcome: Primary: Change in Health Related Quality of Life Following Cochlear Implant Treatment — 0.14; 0.22; 0.08 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Commercial Nucleus Cochlear Implant Systems (Device)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Health Related Quality of Life Following Cochlear Implant Treatment |
0.13; 0.25; 0.08 | — |
| PRIMARY Change in Health Related Quality of Life Following Cochlear Implant Treatment |
0.13; 0.25; 0.08 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03072862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.