Evaluation of a New 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: January 27, 2013
Last verified: January 2013
  Purpose

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: Sound Processing Strategy for the HiResolution™ Bionic Ear System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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).

  • Device-related adverse events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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
Active Comparator: Control - HiRes Fidelity 120
Initial subject use of Control condition for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System condition for the second week.
Device: Sound Processing Strategy for the HiResolution™ Bionic Ear System
Control Condition is currently marketed sound processing strategy. Experimental Condition is newly modified sound processing strategy.
Experimental: Experimental Sound Processing Strategy
Initial subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System condition during first week, followed by subject use of the Control condition for the second week.
Device: Sound Processing Strategy for the HiResolution™ Bionic Ear System
Control Condition is currently marketed sound processing strategy. Experimental Condition is newly modified sound processing strategy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral or bilateral user of CII/HiRes 90K 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 ClinicalTrials.gov identifier: NCT01616576

Locations
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

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
Last Updated: January 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Advanced Bionics:
cochlear implant
adults
HiResolution
Fidelity 120
listening benefits
noise
cochlear implant benefit

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014