Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01616576|
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : August 15, 2014
Last Update Posted : September 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Severe-to-profound Hearing Loss, in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System||Device: Control first, then Experimental Device: Experimental first, then Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
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.
Device: Control first, then Experimental
Control condition is currently marketed sound processing strategy.
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.
Device: Experimental first, then Control
Experimental condition is newly modified sound processing strategy.
- 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 ]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.
- Device-related Adverse Events [ Time Frame: 2 weeks ]Device-related adverse events will be assessed to determine whether they impact current device safety performance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616576
|United States, California|
|House Ear Clinic|
|Los Angeles, California, United States, 90057|
|United States, Florida|
|Tampa Bay Hearing and Balance|
|Tampa, Florida, United States, 33606|
|United States, Illinois|
|Carle Clinic Association|
|Urbana, Illinois, United States, 61801|
|United States, Missouri|
|Midwest Ear Institute (MEI)|
|Kansas City, Missouri, United States, 64111|
|Saint Louis, Missouri, United States, 63110|