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CompletedNCT05763342OFITUpdated Feb 9, 2026

A Study of Objective Fitting for Focused Multipolar Stimulation

An interventional study of The Phoenix Research System in Hearing Loss, Bilateral, sponsored by Cochlear. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Cochlear · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this exploratory study is to trial various objective and behavioural fitting methods for potential use with Focused Multipolar Stimulation programming.

Read the detailed description

This study will compare various objective and behavioural fitting methods for the programming of Focused Multipolar Stimulation. Fitting methods will be assessed for both performance and clinician-rated experience to determine the most practical and beneficial method to balance ease of fitting and performance. Focused Multipolar Stimulation (FMS) is an alternative to the standard of care Monopolar Stimulation (MP). FMS may improve spectral resolution through reduced cochlear spread of excitation and in turn provide enhanced speech perception and real-world clinical improvement over MP stimulation.

02

Conditions studied

  • Hearing Loss, Bilateral
03

In context

Hearing Loss, Bilateral

79 studies on the registry are indexed under Hearing Loss, Bilateral; 23 are open to participants now.

This study's enrollment of 15 is below the median of 25 across 62 interventional studies indexed under Hearing Loss, Bilateral.

Browse Hearing Loss, Bilateral studies →

Lead sponsor

Cochlear is the lead sponsor of 91 studies on the registry; 11 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 15 (94%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Adult Cochlear Implant

    Adult cochlear implant recipients receiving different focused multipolar maps that are programmed using either behavioural or objective methods

    Device: The Phoenix Research System

Interventions

  • DeviceThe Phoenix Research System

    Focused Multipolar Stimulation (FMS) strategy in adult cochlear implant recipients.

06

What researchers measure

Primary outcomes

  1. Speech reception threshold (SRT) in noise as a signal-to-noise ratio for 50% correct score.

    Difference in speech reception threshold (SRT) between objectively fit and behaviourally fit maps using the Spanish Hearing in Noise Test (HINT) to measure the SRT, reported as a signal-to-noise ratio for 50% correct score.

    Time frame: 6 months

07

Study locations

1 site
  • Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria
    Las Palmas de Gran Canaria, Las Palmas 35016, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05763342
Lead sponsor
Cochlear
Responsible party
Sponsor
First posted
Mar 10, 2023
Start date
Feb 8, 2024
Primary completion
Oct 20, 2025
Completion
Nov 26, 2025
Last update
Feb 9, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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