Reducing follow-up visits for cochlear implant patients using a new mapping strategy
Improving Clinical Efficiency by Reducing Scheduled Follow-ups Using Cochlear America's Population Mean Mapping Strategy
This study is testing a new way to program cochlear implants to see if adults can have fewer follow-up visits while still feeling satisfied and hearing well.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Massachusetts Eye and Ear Infirmary Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06960616 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a new programming strategy from Cochlear Americas aimed at improving clinical efficiency by reducing the number of scheduled follow-up appointments for cochlear implant recipients. Investigators will assess whether patient outcomes remain stable with fewer follow-ups and if Cochlear's population mean mapping can achieve similar results as traditional methods. The study focuses on adults who have recently chosen Cochlear Americas for their cochlear implants and will involve follow-up testing tasks to measure performance outcomes. The goal is to determine if reducing appointment frequency can maintain patient satisfaction and hearing performance.
Who should consider this trial
Good fit: Ideal candidates are postlingually deafened adults aged 18 and older who are new recipients of Cochlear Americas devices and can perform follow-up testing tasks.
Not a fit: Patients who choose cochlear implants from other manufacturers or have pre-lingual deafness may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could streamline the follow-up process for cochlear implant patients, saving time and resources while maintaining effective outcomes.
How similar studies have performed: While the approach of reducing follow-up visits is innovative, similar studies have not been widely reported, making this a potentially novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Postlingually deafened * Adults (18+) * New cochlear implant recipients with Cochlear Americas devices; identified prior to activation * Able to perform follow-up testing tasks (repeating words/sentences, indicating they heard a sound stimulus, completing questionnaires) * English speakers Exclusion Criteria: * Patients who select other cochlear implant manufactured devices * Pre-lingually deafened * Multiple disabilities * Unable to perform follow-up testing tasks (repeating words/sentences, indicating they heard a sound stimulus, completing questionnaires) * Non-English speakers * Children under the age of 18
Where this trial is running
Boston, Massachusetts
- Mass Eye and Ear — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Julie Arenberg — Massachusetts Eye and Ear
- Study coordinator: Arenberg
- Email: julie_arenberg@meei.harvard.edu
- Phone: 6178077904
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.