Evaluating remote programming for cochlear implants during follow-up
Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up
Advanced Bionics AG · NCT06894303
This study is testing if remote programming for cochlear implants can help people hear as well as traditional in-office programming while also gathering their feedback on the experience.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 51 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Advanced Bionics AG (industry) |
| Locations | 1 site (Paris) |
| Trial ID | NCT06894303 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and efficacy of remote programming for cochlear implants using the Target CI version 1.5 and the AB Remote Support app. It is a non-interventional, monocentric investigation that compares hearing outcomes from remote programming to traditional in-office programming. The study employs a non-inferiority design to determine if sentence recognition in noise is comparable between the two methods. Participants will provide feedback on their hearing experiences after using the remote programming feature.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have been implanted with specific HiResolution Bionic Ear Systems and have at least six months of cochlear implant experience.
Not a fit: Patients with unrealistic expectations about the benefits of the device or those with potential device malfunctions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the convenience and accessibility of cochlear implant follow-up care for patients.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a relatively novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to provide informed consent * Ability to give feedback on hearing impressions * Aged 18 years of age or older * Implanted with a HiResolution Bionic Ear System (HiRes 90K or HiRes 90K Advantage or HiRes Ultra or HiRes Ultra 3D) on at least one side * Group 1 - Unilateral: no hearing device except contralateral routing of signals (CROS) device on the contralateral side * Group 2 - Bilateral: implanted on both sides * Group 3 - Bimodal: hearing aid on the contralateral side * Minimum of six months of cochlear implant experience * Minimum of one month experience with a Naída CI M or Sky CI M sound processor * Fluent in French language * Ability to be tested via speech perception test in noise * Smartphone user Exclusion Criteria: * Clinical presentation indicative of potential implanted device malfunction * Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the Investigator * Unwillingness or inability of subject to comply with all investigational requirements as determined by the Investigator Pregnancy and breast-feeding are not exclusion criteria.
Where this trial is running
Paris
- Groupement Hospitalier Pitié Salpêtrière — Paris, France (RECRUITING)
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.
Conditions: Cochlear Hearing Loss