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
1 other identifier
interventional
22
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2019
Shorter than P25 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 17, 2019
CompletedFirst Submitted
Initial submission to the registry
January 7, 2020
CompletedFirst Posted
Study publicly available on registry
January 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2020
CompletedResults Posted
Study results publicly available
May 13, 2022
CompletedMay 13, 2022
April 1, 2022
10 months
January 7, 2020
February 4, 2022
April 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Speech Recognition in Noise
1 Day
Increased Speech Recognition in Noise
1 Day
Study Arms (2)
Aidable Residual Hearing (ARH) Cohort
OTHERControl Device followed by experimental Device.
Electric Only (EO) Cohort
OTHERControl Device followed by experimental Device.
Interventions
Control cochlear implant sound processor
New cochlear implant sound processor
Eligibility Criteria
You may qualify if:
- Ability to provide Informed Consent
- 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
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Advanced Bionicslead
Study Sites (6)
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Tampa Bay Hearing and Balance Center
Tampa, Florida, 33606, United States
Midwest Ear Institute/St. Luke's Health System
Kansas City, Missouri, 64111, United States
Washington University Medical Center
St Louis, Missouri, 63110, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Austin Ear, Nose & Throat Clinic
Austin, Texas, 78731, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to clinic closures related to the COVID-19 pandemic, total enrollment in the EO Cohort was 10 subjects instead of 12.
Results Point of Contact
- Title
- Ankur Kaushal, VP of Global Regulatory Affairs
- Organization
- Advanced Bionics, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2020
First Posted
January 23, 2020
Study Start
December 17, 2019
Primary Completion
October 15, 2020
Study Completion
October 15, 2020
Last Updated
May 13, 2022
Results First Posted
May 13, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share