Can remote check-ups replace clinic visits for cochlear implant patients?

NCT ID NCT05552118

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether managing cochlear implant care remotely (via phone or app) works as well as going to the clinic. About 148 adults with hearing loss will be followed for a year after their implant is activated. The goal is to see if remote care saves time and money while keeping hearing improvement on track.

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 148 people

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

Started

Mar 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Aged 18 years or older (no upper age limit) * Post-lingually deafened or pre-lingually deafened with measurable word scores in quiet using a cochlear implant * Unilaterally implanted with a compatible Cochlear™ implant * Currently using a compatible Cochlear™ Sound Processor * 3 months, +/- 2 weeks, experience with a cochlear implant (post-activation) at the time of baseline measurements * Direct access to a compatible Smart Phone * Fluent in the languages used for the study, as determined by the investigator * Willing to participate in and comply with all requirements of the protocol, including willingness to be randomised to either arm * Willing and able to provide written informed consent Exclusion Criteria: * Patient has a MAP incompatible with Master Volume, Bass and Treble (MVBT) programming: * Non-monopolar MAPs (bipolar, common ground, variable mode) * Dynamic range of \<10 Comfortable Level (CL) * Hybrid mode enabled * Pulse widths \>100 µs * 10 or more electrodes turned off * Patient has on-going fluctuations in MAP Threshold levels (Ts) and Comfort levels (Cs) and/or impedances * Patient requires frequent individual channel measurements and/or measurements without the use of live-stimulation * Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire (MDPQ) * Abnormal cochlea anatomy and/or facial nerve stimulation that requires complex or more frequent programming, as determined by the Investigator * Additional disabilities that would prevent participation in evaluations, including significant visual impairment and/or dexterity issues * Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator * Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling * Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation * Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6229 EV, Netherlands

  • Auditory Implant Centre, Glan Clwyd Hospital

    Bodelwyddan, LL18 5UJ, United Kingdom

  • Azienda Ospedale Università di Padova

    Padova, 35128, Italy

  • Ear Science Institute Australia

    Subiaco, Western Australia, 6008, Australia

  • Queen Elizabeth Hospital Audiology Centre - University Hospital Birmingham

    Birmingham, B15 2TH, United Kingdom

  • Radboud University Medical Centre Nijmegen

    Nijmegen, 6500 HB, Netherlands

  • St George's Hospital

    London, SW17 0QT, United Kingdom

  • St Thomas' Hospital

    London, SE1 7EH, United Kingdom

  • UZ Gent

    Ghent, 9000, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • University of Bari "A. Moro" UOC Otorinolaringoiatria Universitaria

    Bari, 70120, Italy

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