A Study of Objective Fitting for Focused Multipolar Stimulation (OFIT)

February 5, 2026 updated by: Cochlear

An Early Feasibility, Prospective, Exploratory Study Investigating the Use of Objective Measures to Inform Focused Multipolar Fitting in Adult Cochlear Implant Recipients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Focused Multipolar Stimulation (FMS) strategy in adult cochlear implant recipients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech reception threshold (SRT) in noise as a signal-to-noise ratio for 50% correct score.
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2024

Primary Completion (Actual)

October 20, 2025

Study Completion (Actual)

November 26, 2025

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI5817

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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