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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
Sponsor:
Information provided by (Responsible Party):
Advanced Bionics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (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
Enrollment 36
Recruitment Details 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  
Arm/Group Title Control First, Then Experimental (Group A) Experimental First, Then Control (Group B)
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 18 18
Completed 18 18
Not Completed 0 0
Arm/Group Title Control First, Then Experimental (Group A) Experimental First, Then Control (Group B) Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  55.6%
11
  61.1%
21
  58.3%
>=65 years
8
  44.4%
7
  38.9%
15
  41.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
62.0  (14.81) 58.9  (13.86) 60.4  (14.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
10
  55.6%
9
  50.0%
19
  52.8%
Male
8
  44.4%
9
  50.0%
17
  47.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 18 participants 36 participants
18 18 36
1.Primary Outcome
Title Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.
Hide Description 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A and Group B Data Pooled Control Experimental
Hide Arm/Group Description:
Data from Group A (n=18) and Group B (n=18) were pooled for the statistical analyses. Control data consists of Week 1 data from Group A and Week 2 data from Group B; Experimental data consisted of Week 2 data from Group A and Week 1 data from Group B. The resulting mean Control score was subtracted from the mean Experimental score to yield a paired difference score (i.e. Experimental - Control = paired difference score). The paired difference score (n=36) is reported below for each listening condition.
Data from Group A and Group B were pooled for the statistical analyses. Control data consists of Week 1 data from Group A and Week 2 data from Group B.
Data from Group A and Group B were pooled for the statistical analyses. Experimental data consisted of Week 2 data from Group A and Week 1 data from Group B.
Overall Number of Participants Analyzed 36 36 36
Mean (Standard Deviation)
Unit of Measure: Percent Correct
Quiet 0.2  (6.06) 88.3  (11.15) 88.5  (12.43)
SSN 2.8  (8.28) 61.2  (18.98) 64.0  (18.11)
MTB 2.2  (6.89) 67.8  (17.13) 70.0  (16.53)
2.Primary Outcome
Title Device-related Adverse Events
Hide Description Device-related adverse events will be assessed to determine whether they impact current device safety performance.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control First, Then Experimental (Group A) Experimental First, Then Control (Group B)
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 18 18
Measure Type: Number
Unit of Measure: Events
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control First, Then Experimental (Group A) Experimental First, Then Control (Group B)
Hide Arm/Group Description

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 condition for the second week.

Control Sound Processing Strategy: HiRes Fidelity 120™ 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.

Initial subject use of Experimental 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.

Control Sound Processing Strategy: HiRes Fidelity 120™ 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.

All-Cause Mortality
Control First, Then Experimental (Group A) Experimental First, Then Control (Group B)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Control First, Then Experimental (Group A) Experimental First, Then Control (Group B)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/18 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control First, Then Experimental (Group A) Experimental First, Then Control (Group B)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/18 (11.11%)      3/18 (16.67%)    
General disorders     
Headache   1/18 (5.56%)  1 3/18 (16.67%)  3
Cold   1/18 (5.56%)  1 0/18 (0.00%)  0
Indicates events were collected by systematic assessment
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.
PI agrees to submit any publication to Sponsor (S) at least 30 days prior to submission. Within 30 days of its receipt, S advises PI in writing of any information contained therein which is Confidential Information (CI) (other than Study Data) or which may impair the availability of patent protection for Inventions. S has the right to require PI to remove specifically identified CI and/or to delay the publication for an additional 60 days to enable S to seek patent protection for Inventions.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cedric Navarro, Vice President of Regulatory/Clinical Affairs and Quality
Organization: Advanced Bionics, LLC
Phone: (661) 362-1963
EMail: Clinical.Research@advancedbionics.com
Layout table for additonal information
Responsible Party: Advanced Bionics
ClinicalTrials.gov Identifier: NCT01616576    
Other Study ID Numbers: CR0611
First Submitted: June 1, 2012
First Posted: June 12, 2012
Results First Submitted: February 26, 2014
Results First Posted: August 15, 2014
Last Update Posted: September 5, 2014