Clinical Evaluation of a Cochlear Implant Sound Processor

April 20, 2022 updated by: Advanced Bionics

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa Bay Hearing and Balance Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Midwest Ear Institute/St. Luke's Health System
      • Saint Louis, Missouri, United States, 63110
        • Washington University Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Austin, Texas, United States, 78731
        • Austin Ear, Nose & Throat Clinic

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 Day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1 Day
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.
1 Day

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Advanced Bionics

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR1218

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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