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

Primary Purpose

Hearing Loss, Bilateral

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
The Phoenix Research System
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hearing Loss, Bilateral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adult Cochlear Implant

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2023
Last Updated
July 30, 2023
Sponsor
Cochlear
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1. Study Identification

Unique Protocol Identification Number
NCT05763342
Brief Title
A Study of Objective Fitting for Focused Multipolar Stimulation
Acronym
(OFIT)
Official Title
An Early Feasibility, Prospective, Exploratory Study Investigating the Use of Objective Measures to Inform Focused Multipolar Fitting in Adult Cochlear Implant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 30, 2023 (Anticipated)
Primary Completion Date
October 30, 2025 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Bilateral

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adult Cochlear Implant
Arm Type
Experimental
Arm Description
Adult cochlear implant recipients receiving different focused multipolar maps that are programmed using either behavioural or objective methods
Intervention Type
Device
Intervention Name(s)
The Phoenix Research System
Intervention Description
Focused Multipolar Stimulation (FMS) strategy in adult cochlear implant recipients.
Primary Outcome Measure Information:
Title
Speech reception threshold (SRT) in noise as a signal-to-noise ratio for 50% correct score.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Fung
Phone
3038807305
Email
afung@cochlear.com
Facility Information:
Facility Name
Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria
City
Las Palmas De Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35016
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Prof. Angel Ramos Macias, Doctor

12. IPD Sharing Statement

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A Study of Objective Fitting for Focused Multipolar Stimulation

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