Evaluating the societal impact of cochlear implants on adults with hearing loss
Societal Merit of Intervention on Hearing Loss Evaluation - Investigating the Impact of (Waiting for) Cochlear Implantation in People With Severe to Profound Sensorineural Hearing Loss on Societal Related Outcomes.
This study is testing how getting cochlear implants affects the daily lives and well-being of adults with hearing loss, including their communication and independence.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 156 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 5 sites (Nijmegen, Gelderland and 4 other locations) |
| Trial ID | NCT05525221 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term effects of cochlear implantation on societal outcomes for adults with progressive moderate to profound sensorineural hearing loss. It will evaluate various factors such as communication, autonomy, cognition, and quality of life before and after the intervention. Additionally, the study will investigate how the waiting time for cochlear implant surgery affects these societal outcomes. By gathering empirical data, the study seeks to highlight the importance of timely cochlear implantation for improving patients' societal participation and overall well-being.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with moderate to severe-to-profound sensorineural hearing loss who are eligible for cochlear implantation.
Not a fit: Patients with prelingual onset of deafness or those with complex syndromes and multiple health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide crucial evidence supporting the benefits of cochlear implants in enhancing the quality of life and societal participation for adults with hearing loss.
How similar studies have performed: While the societal impact of cochlear implants has been explored, this study aims to provide novel empirical data specifically focused on the societal outcomes of adults with progressive hearing loss.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (potentially) eligible for CI according to the Dutch quality standard for CI (Veldnorm CI 2013) and willing to participate. Participants are divided in 2 age categories (under and over 65 years old) Exclusion Criteria: * People with a complex syndrome with multiple problems. * Incapable of performing paid or unpaid labor, due to non-hearing related factors * Prelingual onset of deafness. * Children 0 - 18 years old. * Non-native Dutch speakers. * Patients suffering from a psychiatric disorder * Any condition that may hamper a complete insertion of the electrode array or a normal rehabilitation with the cochlear implant (severe otosclerosis or neurologic deficits)
Where this trial is running
Nijmegen, Gelderland and 4 other locations
- Radboudumc — Nijmegen, Gelderland, Netherlands (Recruiting)
- Maastricht UMC+ — Maastricht, Limburg, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, Noord-Holland, Netherlands (Recruiting)
- Leids UMC — Leiden, Zuid-Holland, Netherlands (Recruiting)
- UMC Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Wendy Huinck
- Email: Wendy.huinck@radboudumc.nl
- Phone: +316 024 361 1111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.