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Taking people in FranceNo phase

Remote Adjustment of Cochlear Implants for Adults With Hearing Loss

Compares remote cochlear implant adjustment with in-office adjustment for hearing speech in noise.

Key facts

Who runs it
Advanced Bionics AG
Where
Paris, FranceSee the site
Trial code
Registry title
Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up
Status
Recruiting
People taking part
51 people, planned
Started
3 Feb 2025
Expected to end
Dec 2026
Type of study
Observational, 3 groups
Treatments tested
  • Target CI v1.5 remote programming
Record updated
20 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a HiResolution Bionic Ear cochlear implant. It tests whether programming the implant remotely works as well as programming it in the clinic.

Age
18 years or older
Sex
All sexes can join
Disease stage
Hearing loss treated with a HiRes 90K, HiRes 90K Advantage, HiRes Ultra or HiRes Ultra 3D implant on at least one side. People can join with an implant on one side only (no hearing device on the other side, except a CROS device), implants on both sides, or an implant plus a hearing aid on the other side.
Earlier treatment
At least six months of cochlear implant use. At least one month of use of a Naída CI M or Sky CI M sound processor.

Main reasons for not taking part

  • Signs that the implant may not be working properly
  • Expectations about the device that the investigator judges unrealistic
  • Not willing or not able to follow all study requirements
  • Not fluent in French
  • Not a smartphone user or cannot do a speech test in noise

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the Investigator
  • Clinical presentation indicative of potential implanted device malfunction
  • 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 in France

  • Groupement Hospitalier pitié SalpêtrièreParis, FranceContact: Isabelle MosnierTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Group 1

    Unilateral users

    Treatment: Target CI v1.5 remote programming

  • Group 2

    Bilateral users

    Treatment: Target CI v1.5 remote programming

  • Group 3

    Bimodal users

    Treatment: Target CI v1.5 remote programming

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up
Plain-language title
Remote Adjustment of Cochlear Implants for Adults With Hearing LossGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
20 May 2026