Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up

May 19, 2026 updated by: Advanced Bionics AG
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Recruiting
        • Groupement Hospitalier Pitié Salpêtrière
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Advanced Bionics adults CI users

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Unilateral users
Device: Target CI v1.5 remote programming
Use of the remote programming function of Target CI v1.5 and the AB remote support application
Group 2
Bilateral users
Device: Target CI v1.5 remote programming
Use of the remote programming function of Target CI v1.5 and the AB remote support application
Group 3
Bimodal users
Device: Target CI v1.5 remote programming
Use of the remote programming function of Target CI v1.5 and the AB remote support application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
50% SRT measured as signal to noise ratio in DB (French Matrix test in noise)
Time Frame: one-month chronic use of remotely fitted sound processor
The primary efficacy objective is to demonstrate that speech recognition in noise after remote fitting is no worse than speech recognition in noise after in-office fitting.
one-month chronic use of remotely fitted sound processor

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score in the Lafon phoneme test in quiet
Time Frame: one-month chronic use of remotely fitted sound processor
The secondary efficacy objective is to demonstrate that speech recognition in quiet after remote fitting is no worse than speech recognition in quiet after in-office fitting.
one-month chronic use of remotely fitted sound processor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Bionics AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABInt-24-23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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