Improving cochlear implant fitting and training for better hearing outcomes
Auditory Diagnostics and Error-based Treatment
This study is testing a new program to improve cochlear implant fitting and training for adults who lost their hearing later in life, to help them hear better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT05307952 on ClinicalTrials.gov |
What this trial studies
This study evaluates an integrated program designed to enhance cochlear implant fitting and personalized auditory training for adults who are post-lingually deafened. Participants will undergo diagnostic tests and receive tailored interventions based on their individual speech recognition performance. The program includes follow-up visits and self-administered training using a mobile application over a period of approximately five months. The goal is to reduce variability in hearing outcomes and address specific error patterns in speech perception.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who are post-lingually deafened, native Dutch speakers, and have been implanted with specific Cochlear Ltd cochlear implants for at least 12 months.
Not a fit: Patients with severe cognitive disorders, abnormally formed cochleas, or other significant health issues that affect their ability to participate may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved speech perception and overall hearing outcomes for cochlear implant recipients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving cochlear implant outcomes through personalized interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (over 18 years old at the time of inclusion ) * Post-lingually deafened (the subject had a good mastery of spoken language before onset of deafness) * Native Dutch speaker * Implanted, either unilaterally or bilaterally, with a Cochlear Implant manufactured by Cochlear Ltd (i.e., a Nucleus ® implant). * Implanted with one of the following implants: CI422, CI512, CI522, CI532, CI24M, CI24R, CI24RE. * Implanted for at least 12 months. Exclusion Criteria: * Known abnormally formed cochlea * Known pre-implantation ossification of the cochlea * Severe cognitive disorders affecting their ability to understand spoken language * Intense facial nerve stimulation * Unaddressed electrode tip foldover * More than 4 electrodes deactivated because of malfunction (open/short circuit) or lack of response * Additional illnesses or handicaps that could impact ability to participate in study, at the clinician's discretion.
Where this trial is running
Nijmegen, Gelderland
- Radboud university medical center — Nijmegen, Gelderland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Wendy Huinck, PhD — Radboud University Medical Center
- Study coordinator: Wendy Huinck, PhD
- Email: Wendy.Huinck@radboudumc.nl
- Phone: +31243613506
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.