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Clinical Evaluation of a Cochlear Implant Sound Processor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04237207
Recruitment Status : Completed
First Posted : January 23, 2020
Results First Posted : May 13, 2022
Last Update Posted : May 13, 2022
Sponsor:
Information provided by (Responsible Party):
Advanced Bionics

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

Condition or disease Intervention/treatment Phase
Hearing Loss Ear Diseases Hearing Disorders Otorhinolaryngologic Diseases Device: Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software Device: 301-M062 sound processor & software Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 17, 2019
Actual Primary Completion Date : October 15, 2020
Actual Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Aidable Residual Hearing (ARH) Cohort
Control Device followed by experimental Device.
Device: Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software
Control cochlear implant sound processor

Device: 301-M062 sound processor & software
New cochlear implant sound processor

Electric Only (EO) Cohort
Control Device followed by experimental Device.
Device: Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software
Control cochlear implant sound processor

Device: 301-M062 sound processor & software
New cochlear implant sound processor




Primary Outcome Measures :
  1. Speech Recognition in Quiet [ Time Frame: 1 Day ]
    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 :
  1. Speech Recognition in Noise [ Time Frame: 1 Day ]
    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.

  2. Increased Speech Recognition in Noise [ Time Frame: 1 Day ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237207


Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
United States, Florida
Tampa Bay Hearing and Balance Center
Tampa, Florida, United States, 33606
United States, Missouri
Midwest Ear Institute/St. Luke's Health System
Kansas City, Missouri, United States, 64111
Washington University Medical Center
Saint Louis, Missouri, United States, 63110
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Austin Ear, Nose & Throat Clinic
Austin, Texas, United States, 78731
Sponsors and Collaborators
Advanced Bionics
  Study Documents (Full-Text)

Documents provided by Advanced Bionics:
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Responsible Party: Advanced Bionics
ClinicalTrials.gov Identifier: NCT04237207    
Other Study ID Numbers: CR1218
First Posted: January 23, 2020    Key Record Dates
Results First Posted: May 13, 2022
Last Update Posted: May 13, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hearing Loss
Ear Diseases
Hearing Disorders
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases