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Could remote Check-Ups replace frequent clinic visits for cochlear implant users?

NCT ID NCT07117968

Symptom relief Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a new care pathway for adults getting a cochlear implant. Instead of the usual nine clinic visits in the first year, the new plan uses early activation of the implant and remote monitoring visits. The goal is to see if this approach is at least as good for hearing performance while improving quality of life and reducing the burden on patients and clinics. About 130 adults with severe to profound deafness will take part across multiple centers in France.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
remote monitoring and early activation of cochlear implant
What this could lead to
If successful, this could make cochlear implant follow-up more convenient and flexible for patients, reducing travel and clinic visits.
What could go wrong
This is a non-inferiority trial, so it may only show that the new approach is no worse than standard care, not necessarily better. The study is also small (130 participants) and not yet recruiting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patients (aged 18 or over) eligible for a cochlear implant in primary implantation according to French National Authority for Health indications * Patients suffering from severe to profound bilateral deafness with discrimination less than or equal to 50% on voice audiometry tests using the Fournier list (or equivalent). * Patients affiliated to the public health insurance body * Patients who benefit from a Cochlear® system with a processor compatible with Remote Care tools * Patients using a smartphone compatible with the Nucleus Smart application. * Patients who have given their written informed consent to the study * French-speaking patients Exclusion Criteria: * Patients already implanted and candidates for implantation of the other ear (bilateralization), or previously implanted (re-implantation). * Patients with concomitant illnesses that are incompatible with the use of remote monitoring, * Pregnant women * Patients suffering from unilateral deafness with incapacitating tinnitus * Persons under legal protection (guardianship, curators). * Subjects taking part in other interventional research with an exclusion period still in progress at the time of inclusion.

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Conditions

The condition(s) this trial relates to.

Deafness hearing loss disorder prelingual non-syndromic genetic hearing loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Deafness

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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Other studies related to the condition(s) this trial covers.