Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up
Recruiting now
Conditions studied: Cochlear Hearing Loss
In brief
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.
Key facts
- Study ID
- NCT06894303
- Run by
- Advanced Bionics AG
- People needed
- 51
- Starts
- 2025-02-03
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-05-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Groupement Hospitalier Pitié Salpêtrière — Paris, France (enrolling)
Full record on ClinicalTrials.gov
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