- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01616576
Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
July 8, 2020 updated by: Advanced Bionics
The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- 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
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California
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Los Angeles, California, United States, 90057
- House Ear Clinic
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Florida
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Tampa, Florida, United States, 33606
- Tampa Bay Hearing and Balance
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Illinois
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Urbana, Illinois, United States, 61801
- Carle Clinic Association
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Missouri
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Kansas City, Missouri, United States, 64111
- Midwest Ear Institute (MEI)
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Saint Louis, Missouri, United States, 63110
- Washington University
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Unilateral or bilateral user of CII/HiRes90K™ implant(s) (minimum of one year in each implanted ear), Harmony™ BTE processor(s) with HiRes Fidelity 120™ (with or without ClearVoice™) as preferred sound processing strategy
- 18 years of age or older at time of implant
- Postlingual onset of severe-to-profound hearing loss (≥ 6 years of age)
- At least moderate open-set speech recognition abilities (defined as CNC word score ≥ 50% in medical records or assessed at the Baseline Visit with implant alone for unilateral users, with both implants together for bilateral users)
- English language proficiency
- Willingness to use a Harmony™ BTE processor and refrain from ClearVoice™ use for the duration of the study
- Willingness and ability to participate in all scheduled procedures outlined in the protocol
Exclusion Criteria:
• Presence of any additional disabilities that would prevent or interfere with participation in the required speech perception testing
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control first, then Experimental (Group A)
Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental (HiRes™ Optima) Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.
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Control condition is currently marketed sound processing strategy.
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Experimental: Experimental first, then Control (Group B)
Initial subject use of Experimental (HiRes™ Optima) Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of the Control Sound Processing Strategy for the second week.
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Experimental condition is newly modified sound processing strategy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.
Time Frame: 2 weeks
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Sentence recognition with the new (experimental) and current (control) sound processing strategies will be compared.
Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility.
The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores).
Data from both Group A and Group B were pooled for the analysis.
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2 weeks
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Device-related Adverse Events
Time Frame: 2 weeks
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Device-related adverse events will be assessed to determine whether they impact current device safety performance.
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2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
May 1, 2012
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
June 1, 2012
First Submitted That Met QC Criteria
June 8, 2012
First Posted (Estimate)
June 12, 2012
Study Record Updates
Last Update Posted (Actual)
July 22, 2020
Last Update Submitted That Met QC Criteria
July 8, 2020
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR0611
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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