Clinical Evaluation of a Cochlear Implant Sound Processor

Not Applicable

Completed

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

• Registration Number: NCT04237207
• Lead Sponsor: 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

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 Timeline

• Study Start: 2019-12-17
• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-23
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15
• Results First Submitted: 2022-02-04
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-20
• Last Update Submitted: 2022-04-20
• Results First Posted: 2022-05-13
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aidable Residual Hearing (ARH) Cohort	Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software	Control Device followed by experimental Device.
Aidable Residual Hearing (ARH) Cohort	301-M062 sound processor & software	Control Device followed by experimental Device.
Electric Only (EO) Cohort	301-M062 sound processor & software	Control Device followed by experimental Device.
Electric Only (EO) Cohort	Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software	Control Device followed by experimental Device.

Primary Outcome Measures

Name	Time	Method
Speech Recognition in Quiet	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

Name	Time	Method
Speech Recognition in Noise	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.
Increased Speech Recognition in Noise	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.

Trial Locations

Locations (6)

Midwest Ear Institute/St. Luke's Health System; 🇺🇸 Kansas City, Missouri, United States

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Tampa Bay Hearing and Balance Center; 🇺🇸 Tampa, Florida, United States

Washington University Medical Center; 🇺🇸 Saint Louis, Missouri, United States

Austin Ear, Nose & Throat Clinic; 🇺🇸 Austin, Texas, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States