Evaluating remote programming for cochlear implants during follow-up

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Groupement Hospitalier Pitié Salpêtrière
  Paris, France Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Analysis of speech performance in cochlear implant users

  This study looks at how well people with HiRes Ultra and HiRes Ultra 3D cochlear implants can understand speech to see if these devices really help improve their hearing.

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• Understanding how cochlear implants affect emotional communication

  This study is testing how cochlear implants affect the way children and adults understand and express emotions in speech.

  Recruiting at 3 sites Early Phase 1 Father Flanagan's Boys' Home · Tempe, Arizona and 3 other locations · NCT05486637

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.