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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

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

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

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

Arm Label

Aidable Residual Hearing (ARH) Cohort

Electric Only (EO) Cohort

Arm Description

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

NCT ID

NCT04237207

First Posted

January 7, 2020

Last Updated

April 20, 2022

Sponsor

Advanced Bionics

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

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

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

Time Frame

1 Day

Secondary Outcome Measure Information:

Title

Speech Recognition in Noise

Description

Time Frame

1 Day

Title

Increased Speech Recognition in Noise

Description

Time Frame

1 Day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Learn more about this trial

Clinical Evaluation of a Cochlear Implant Sound Processor

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