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Cochlear implant tuning gets a High-Tech upgrade

NCT ID NCT05763342

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new method for programming cochlear implants called Focused Multipolar Stimulation (FMS). Researchers compared two ways to set up the implant: one using objective measurements and another based on the user's feedback. The goal was to see which approach helps adults with severe hearing loss understand speech better in noisy environments. Fifteen participants took part in this early feasibility study.

What this could mean

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

Active substance
Focused Multipolar Stimulation (FMS) programming strategy via the Phoenix Research System
What this could lead to
If successful, this could lead to better hearing in noisy environments for cochlear implant users without lengthy trial-and-error adjustments.
What could go wrong
This is a small, early feasibility study with only 15 participants, so results may not apply to everyone. The new programming method may not improve hearing significantly over current approaches.

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

15 people

The number who actually took part.

Started

Feb 2024

Finished

Nov 2025

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: 1. Moderately severe to profound sensorineural hearing loss in both ears. (i.e., \>55 dB HL pure-tone average loss) 2. Candidate for unilateral cochlear implantation according to locally approved criteria. 3. Aged 18 years or over. 4. Fluent speaker in the language used to assess speech perception performance. 5. Willing and able to provide written informed consent. Exclusion Criteria: 1. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. 2. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. 3. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. 4. Pregnant at the time of surgery. 5. Prisoners, or anyone in custody. 6. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device. 7. Previous or existing cochlear-implant recipient. 8. Evidence of severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age. 9. Duration of severe to profound hearing loss \>20 years in the ear to be implanted. 10. Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array. 11. Diagnosis of auditory neuropathy. 12. Deafness due to lesions of the acoustic nerve or central auditory pathway. 13. Additional handicaps that would prevent or restrict participation in the audiological evaluations. 14. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and prosthetic device.

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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

  • Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria

    Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

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