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

Primary Purpose

Severe to Profound Hearing Loss, in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control first, then Experimental
Experimental first, then Control
Sponsored by
Advanced Bionics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe to Profound Hearing Loss focused on measuring cochlear implant, adults, HiResolution™, Fidelity 120™, listening benefits, noise, cochlear implant benefit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • House Ear Clinic
  • Tampa Bay Hearing and Balance
  • Carle Clinic Association
  • Midwest Ear Institute (MEI)
  • Washington University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control first, then Experimental (Group A)

Experimental first, then Control (Group B)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.
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
Device-related adverse events will be assessed to determine whether they impact current device safety performance.

Secondary Outcome Measures

Full Information

First Posted
June 1, 2012
Last Updated
July 8, 2020
Sponsor
Advanced Bionics
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1. Study Identification

Unique Protocol Identification Number
NCT01616576
Brief Title
Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Bionics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe to Profound Hearing Loss, in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System
Keywords
cochlear implant, adults, HiResolution™, Fidelity 120™, listening benefits, noise, cochlear implant benefit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control first, then Experimental (Group A)
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental first, then Control (Group B)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Control first, then Experimental
Intervention Description
Control condition is currently marketed sound processing strategy.
Intervention Type
Device
Intervention Name(s)
Experimental first, then Control
Intervention Description
Experimental condition is newly modified sound processing strategy.
Primary Outcome Measure Information:
Title
Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.
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
Title
Device-related Adverse Events
Description
Device-related adverse events will be assessed to determine whether they impact current device safety performance.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
House Ear Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Tampa Bay Hearing and Balance
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Carle Clinic Association
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Midwest Ear Institute (MEI)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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

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