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

This study has been completed.
Information provided by (Responsible Party):
Advanced Bionics Identifier:
First received: June 1, 2012
Last updated: August 28, 2014
Last verified: August 2014
The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.

Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Advanced Bionics:

Primary Outcome Measures:
  • 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.

Enrollment: 36
Study Start Date: May 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
Washington University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Advanced Bionics
  More Information

Responsible Party: Advanced Bionics Identifier: NCT01616576     History of Changes
Other Study ID Numbers: CR0611
Study First Received: June 1, 2012
Results First Received: February 26, 2014
Last Updated: August 28, 2014

Keywords provided by Advanced Bionics:
cochlear implant
Fidelity 120™
listening benefits
cochlear implant benefit

Additional relevant MeSH terms:
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on September 21, 2017