Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Advanced Bionics
ClinicalTrials.gov Identifier:
NCT01616576
First received: June 1, 2012
Last updated: July 25, 2014
Last verified: July 2014
Results First Received: February 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Severe-to-profound Hearing Loss,
in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System
Interventions: Device: Control first, then Experimental
Device: Experimental first, then Control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Investigators recruited study subjects from their clinic practice. Subjects were randomized to either Group A or Group B at the time of the baseline visit. First patient first visit occurred on May 25, 2012 and last patient last visit occurred on September 07, 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control First, Then Experimental (Group A)

Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.

Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.

Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System.

Experimental First, Then Control (Group B)

Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.

Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.

Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System.


Participant Flow:   Overall Study
    Control First, Then Experimental (Group A)     Experimental First, Then Control (Group B)  
STARTED     18     18  
COMPLETED     18     18  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control First, Then Experimental (Group A)

Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.

Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.

Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System.

Experimental First, Then Control (Group B)

Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.

Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.

Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System.

Total Total of all reporting groups

Baseline Measures
    Control First, Then Experimental (Group A)     Experimental First, Then Control (Group B)     Total  
Number of Participants  
[units: participants]
  18     18     36  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     11     21  
>=65 years     8     7     15  
Age  
[units: years]
Mean ± Standard Deviation
  62.0  ± 14.81     58.9  ± 13.86     60.4  ± 14.22  
Gender  
[units: participants]
     
Female     10     9     19  
Male     8     9     17  
Region of Enrollment  
[units: participants]
     
United States     18     18     36  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Primary:   Device-related Adverse Events   [ Time Frame: 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Cedric Navarro, Vice President of Regulatory/Clinical Affairs and Quality
Organization: Advanced Bionics, LLC
phone: (661) 362-1963
e-mail: Clinical.Research@advancedbionics.com


No publications provided


Responsible Party: Advanced Bionics
ClinicalTrials.gov Identifier: NCT01616576     History of Changes
Other Study ID Numbers: CR0611
Study First Received: June 1, 2012
Results First Received: February 26, 2014
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration