NCT06894303 Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up
| NCT ID | NCT06894303 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Advanced Bionics AG |
| Condition | Cochlear Hearing Loss |
| Study Type | OBSERVATIONAL |
| Enrollment | 51 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 51 participants in total. It began in 2025-02-03 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective and monocentric clinical investigation, non-interventional and non-randomized. The overall goal of this clinical study is to generate additional clinical data confirming the safety and efficacy of the remote programming functionality of Target CI version 1.5 and the AB Remote Support app. Hearing outcomes are expected to be similar whether a study subject's sound processor is programmed in the traditional method in the audiologist's office or whether programming is performed via remote fitting. Therefore, the study uses a non-inferiority design to determine whether sentence recognition in noise is no worse with remote fitting than in an in-office setting.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT06894303 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cochlear Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06894303 currently recruiting?
Yes, NCT06894303 is actively recruiting participants. Visit ClinicalTrials.gov or contact Advanced Bionics AG to inquire about joining.
Where is the NCT06894303 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06894303 clinical trial?
NCT06894303 is sponsored by Advanced Bionics AG. The trial plans to enroll 51 participants.