Clinical Evaluation of a Cochlear Implant Sound Processor

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: Completed
• Conditions: Otorhinolaryngologic Diseases; Ear Diseases; Hearing Loss; Hearing Disorders
• Intervention / Treatment: Device: Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software; Device: 301-M062 sound processor & software

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: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Day
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.	1 Day

Collaborators and Investigators

• Sponsor: Advanced Bionics

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Actual): October 15, 2020
• Study Completion (Actual): October 15, 2020

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases
• Other Study ID 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