Clinical Evaluation of a Cochlear Implant Sound Processor
Primary Purpose
Hearing Loss, Ear Diseases, Hearing Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software
301-M062 sound processor & software
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
General Inclusion Criteria:
- Ability to provide Informed Consent
- 18 years of age or older
- Unilateral user of a HiResolutionTM Bionic Ear System (HiRes 90KTM, HiRes 90KTM Advantage, HiResTM Ultra, HiResTM Ultra 3D), including bilaterally implanted subjects that only use one implant in their everyday listening modality
- Minimum of 6 months of CI experience
- Having used a Naída CI Q70 or a Naída CI Q90 as their primary processor for a minimum of one month
- Presently using a current steering strategy
- At least moderate open-set speech recognition abilities with implant alone, as defined by achieving a score of ≥ 60% words correct in the AzBio in quiet test using the Naída CI Q90 research processor
- English language proficiency as determined by the investigator
- Willingness to use a BTE processor for the duration of the study
ARH Arm Inclusion Criteria
- Residual low frequency hearing sensitivity (pure tone average of < 70 dB HL for 125, 250, and 500 Hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear
- Willingness to use an in-canal acoustic earhook for the duration of the study
EO Arm Inclusion Criteria
• Severe-to-profound sensorineural hearing loss in the low (pure tone average of ≥ 70 dB HL for 125, 250, and 500 Hz) and high frequencies (pure tone average ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear
Exclusion Criteria:
- Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator
- Unwillingness or physical / cognitive inability of subject to comply with all investigational requirements as determined by the investigator
Sites / Locations
- University of Colorado Anschutz Medical Campus
- Tampa Bay Hearing and Balance Center
- Midwest Ear Institute/St. Luke's Health System
- Washington University Medical Center
- Vanderbilt University Medical Center
- Austin Ear, Nose & Throat Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Aidable Residual Hearing (ARH) Cohort
Electric Only (EO) Cohort
Arm Description
Control Device followed by experimental Device.
Control Device followed by experimental Device.
Outcomes
Primary Outcome Measures
Speech Recognition in Quiet
The primary efficacy endpoints are AzBio sentence recognition scores in quiet at Baseline with the new sound processor as compared to AzBio sentence recognition scores in quiet at Baseline with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Secondary Outcome Measures
Speech Recognition in Noise
Demonstrate that AzBio sentence recognition scores in noise with the new sound processor are no worse than AzBio sentence recognition scores in noise with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Increased Speech Recognition in Noise
Demonstrate increased AzBio sentence recognition scores in noise with the new sound processor when comparing "Omnidirectional" program to AutoSense. Omnidirectional refers to a setting in which the AutoSense feature is not active. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04237207
Brief Title
Clinical Evaluation of a Cochlear Implant Sound Processor
Official Title
Evaluation of AutoSense OS on a Cochlear Implant Sound Processor Programmed With Target CI Fitting Software in Adult Users of the HiResolution Bionic Ear System
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 17, 2019 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Bionics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer). Subjects will be assigned to one of two cohorts based on audiometric results at the Baseline visit
Detailed Description
The overall goal of this clinical study is to demonstrate the safety and efficacy of a cochlear implant sound processor. Hearing outcomes are expected to be similar non-inferior to as compared to the currently approved software and processors. Therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet and in noise is no worse with the new sound processor than with currently approved software on a Q90 processor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aidable Residual Hearing (ARH) Cohort
Arm Type
Other
Arm Description
Control Device followed by experimental Device.
Arm Title
Electric Only (EO) Cohort
Arm Type
Other
Arm Description
Control Device followed by experimental Device.
Intervention Type
Device
Intervention Name(s)
Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software
Intervention Description
Control cochlear implant sound processor
Intervention Type
Device
Intervention Name(s)
301-M062 sound processor & software
Intervention Description
New cochlear implant sound processor
Primary Outcome Measure Information:
Title
Speech Recognition in Quiet
Description
The primary efficacy endpoints are AzBio sentence recognition scores in quiet at Baseline with the new sound processor as compared to AzBio sentence recognition scores in quiet at Baseline with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Speech Recognition in Noise
Description
Demonstrate that AzBio sentence recognition scores in noise with the new sound processor are no worse than AzBio sentence recognition scores in noise with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Time Frame
1 Day
Title
Increased Speech Recognition in Noise
Description
Demonstrate increased AzBio sentence recognition scores in noise with the new sound processor when comparing "Omnidirectional" program to AutoSense. Omnidirectional refers to a setting in which the AutoSense feature is not active. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Time Frame
1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
General Inclusion Criteria:
Ability to provide Informed Consent
18 years of age or older
Unilateral user of a HiResolutionTM Bionic Ear System (HiRes 90KTM, HiRes 90KTM Advantage, HiResTM Ultra, HiResTM Ultra 3D), including bilaterally implanted subjects that only use one implant in their everyday listening modality
Minimum of 6 months of CI experience
Having used a Naída CI Q70 or a Naída CI Q90 as their primary processor for a minimum of one month
Presently using a current steering strategy
At least moderate open-set speech recognition abilities with implant alone, as defined by achieving a score of ≥ 60% words correct in the AzBio in quiet test using the Naída CI Q90 research processor
English language proficiency as determined by the investigator
Willingness to use a BTE processor for the duration of the study
ARH Arm Inclusion Criteria
Residual low frequency hearing sensitivity (pure tone average of < 70 dB HL for 125, 250, and 500 Hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear
Willingness to use an in-canal acoustic earhook for the duration of the study
EO Arm Inclusion Criteria
• Severe-to-profound sensorineural hearing loss in the low (pure tone average of ≥ 70 dB HL for 125, 250, and 500 Hz) and high frequencies (pure tone average ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear
Exclusion Criteria:
Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator
Unwillingness or physical / cognitive inability of subject to comply with all investigational requirements as determined by the investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Tampa Bay Hearing and Balance Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Midwest Ear Institute/St. Luke's Health System
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Austin Ear, Nose & Throat Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of a Cochlear Implant Sound Processor
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