Hearing Loss, BilateralOFITNCT05763342
A Study of Objective Fitting for Focused Multipolar Stimulation
A study testing The Phoenix Research System in people with Hearing Loss, Bilateral, run by Cochlear at 1 site in Spain.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Bilateral
- What is being tested?
- The Phoenix Research System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 8 Feb 2024to 26 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderately severe to profound sensorineural hearing loss in both ears. (i.e., >55 dB HL pure-tone average loss)
- Candidate for unilateral cochlear implantation according to locally approved criteria.
- Aged 18 years or over.
- Fluent speaker in the language used to assess speech perception performance.
- Willing and able to provide written informed consent.
Who cannot join
- 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.
- Pregnant at the time of surgery.
- Prisoners, or anyone in custody.
- Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device.
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- Previous or existing cochlear-implant recipient.
- Evidence of severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age.
- Duration of severe to profound hearing loss >20 years in the ear to be implanted.
- Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
- Diagnosis of auditory neuropathy.
- Deafness due to lesions of the acoustic nerve or central auditory pathway.
- Additional handicaps that would prevent or restrict participation in the audiological evaluations.
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35016
About this study
Official title: 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.
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.
- Conditions
- Hearing Loss, Bilateral
- Being tested
- The Phoenix Research System
- Medical subject headings
- Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Phoenix Research SystemDevice
Focused Multipolar Stimulation (FMS) strategy in adult cochlear implant recipients.
| Study group | Role | What they receive |
|---|---|---|
| Adult Cochlear Implant | Experimental | Adult cochlear implant recipients receiving different focused multipolar maps that are programmed using either behavioural or objective methods Receives: Device: The Phoenix Research System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start8 Feb 2024
- Primary completion20 Oct 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763342
- Sponsor's protocol ID
- AI5817
- Acronym
- OFIT
- Status last verified
- Feb 2026
- First submitted
- 31 Jan 2023
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Feasibility, Prospective, Exploratory Study Investigating the Use of Objective Measures to Inform Focused Multipolar Fitting in Adult Cochlear Implant Recipients
- ClinicalTrials.gov ID
- NCT05763342
- Acronym / sponsor ID
- OFIT / AI5817
- Conditions
- Hearing Loss, Bilateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this exploratory study is to trial various objective and behavioural fitting methods for potential use with Focused Multipolar Stimulation programming.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Cochlear Implant | Experimental | Device: The Phoenix Research SystemAdult cochlear implant recipients receiving different focused multipolar maps that are programmed using either behavioural or objective methods |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Moderately severe to profound sensorineural hearing loss in both ears. (i.e., >55 dB HL pure-tone average loss)
- Candidate for unilateral cochlear implantation according to locally approved criteria.
- Aged 18 years or over.
- Fluent speaker in the language used to assess speech perception performance.
- Willing and able to provide written informed consent.
Key exclusion criteria (14 listed)
- 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.
- Pregnant at the time of surgery.
- Prisoners, or anyone in custody.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Phoenix Research SystemFocused Multipolar Stimulation (FMS) strategy in adult cochlear implant recipients. | Device | Adult Cochlear Implant |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Phoenix Research System in people with Hearing Loss, Bilateral, run by Cochlear at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech reception threshold (SRT) in noise as a signal-to-noise ratio for 50% correct score. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.