Can remote check-ups replace clinic visits for cochlear implant patients?
NCT ID NCT05552118
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 148 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Academisch Ziekenhuis Maastricht
Maastricht, 6229 EV, Netherlands
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Auditory Implant Centre, Glan Clwyd Hospital
Bodelwyddan, LL18 5UJ, United Kingdom
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Azienda Ospedale Università di Padova
Padova, 35128, Italy
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Ear Science Institute Australia
Subiaco, Western Australia, 6008, Australia
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Queen Elizabeth Hospital Audiology Centre - University Hospital Birmingham
Birmingham, B15 2TH, United Kingdom
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Radboud University Medical Centre Nijmegen
Nijmegen, 6500 HB, Netherlands
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St George's Hospital
London, SW17 0QT, United Kingdom
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St Thomas' Hospital
London, SE1 7EH, United Kingdom
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UZ Gent
Ghent, 9000, Belgium
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UZ Leuven
Leuven, 3000, Belgium
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University of Bari "A. Moro" UOC Otorinolaringoiatria Universitaria
Bari, 70120, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new hearing aid strategy cut through the noise?
- Can a new bone conduction implant restore hearing for the long haul?
- Can eye movements reveal the hidden toll of hearing loss?
- A digital helping hand for new hearing aid wearers?