Cochlear implant tuning gets a High-Tech upgrade
NCT ID NCT05763342
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
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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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15 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Nov 2025
- 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: 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
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Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
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