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Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System

Primary Purpose

Hearing Loss

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
HiRes 90K Bionic Ear System
Sponsored by
Advanced Bionics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring HiResolution Bionic Ear, severe to profound hearing loss, bilateral implantation

Eligibility Criteria

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

Inclusion Criteria: No previous implant experience. Age 18 years or older. Postlingual onset of hearing loss. Sensorineural hearing loss of a severe or greater degree in both ears. Normal/patent cochlear anatomy in each ear. English language proficiency. Willingness and ability to participate in all scheduled procedures. Exclusion Criteria: No exclusion criteria specified, except for the opposite of inclusion criteria listed above.

Sites / Locations

  • House Clinic/House Ear Institute
  • California Ear Institute (Let Them Hear Foundation)
  • University of Miami - Cochlear Implant Center
  • Tampa Bay Hearing and Balance Center
  • Carle Clinic Association
  • Spectrum Health
  • Midwest Ear Institute
  • New York University Cochlear Implant Center
  • Dallas Otolaryngology Associates

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

Bilaterally Implanted with HiRes 90K device.

Outcomes

Primary Outcome Measures

Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users.
Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported.

Secondary Outcome Measures

HINT Sentences in Noise
20 sentences presented in noise at fixed levels

Full Information

First Posted
September 13, 2005
Last Updated
February 28, 2012
Sponsor
Advanced Bionics
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1. Study Identification

Unique Protocol Identification Number
NCT00205881
Brief Title
Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System
Official Title
Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (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
Normal hearing listeners gain important everyday benefits from listening with two ears (bilateral hearing) compared to their baseline performance with hearing aids. Advantages of bilateral hearing include the ability to determine where sounds are coming from and the ability to hear sounds and understand speech in noisy environments. Based upon these advantages, this study will (1) evaluate the benefit of hearing with two Bionic Ear implants (one in each ear) and (2) compare HiResolution sound processing with conventional sound processing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
HiResolution Bionic Ear, severe to profound hearing loss, bilateral implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Bilaterally Implanted with HiRes 90K device.
Intervention Type
Device
Intervention Name(s)
HiRes 90K Bionic Ear System
Intervention Description
Cochlear implant system
Primary Outcome Measure Information:
Title
Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users.
Description
Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported.
Time Frame
8 months of bilateral cochlear implant use
Secondary Outcome Measure Information:
Title
HINT Sentences in Noise
Description
20 sentences presented in noise at fixed levels
Time Frame
8 months of bilateral cochlear implant use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: No previous implant experience. Age 18 years or older. Postlingual onset of hearing loss. Sensorineural hearing loss of a severe or greater degree in both ears. Normal/patent cochlear anatomy in each ear. English language proficiency. Willingness and ability to participate in all scheduled procedures. Exclusion Criteria: No exclusion criteria specified, except for the opposite of inclusion criteria listed above.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Joe Osberger
Organizational Affiliation
Advanced Bionics
Official's Role
Study Chair
Facility Information:
Facility Name
House Clinic/House Ear Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
California Ear Institute (Let Them Hear Foundation)
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
University of Miami - Cochlear Implant Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Tampa Bay Hearing and Balance Center
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
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Midwest Ear Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
New York University Cochlear Implant Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Dallas Otolaryngology Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States

12. IPD Sharing Statement

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Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System

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