Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System - Full Text View

Sponsor:	Advanced Bionics
Information provided by:	Advanced Bionics
ClinicalTrials.gov Identifier:	NCT00205881

Purpose

Normal hearing listeners gain important everyday benefits from listening with two ears (bilateral hearing) compared to listening with only one ear. 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.

Condition	Intervention	Phase
Hearing Loss	Device: HiRes 90K Bionic Ear System Other: HiRes 90K Bionic Ear System	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study
Official Title:	Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System

Resource links provided by NLM:

Genetics Home Reference related topics: nonsyndromic deafness

MedlinePlus related topics: Hearing Disorders and Deafness

U.S. FDA Resources

Further study details as provided by Advanced Bionics:

Primary Outcome Measures:

The study will evaluate bilateral vs. unilateral benefit in adults with two Bionic ears. [ Time Frame: Various time points post-activation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The study will assess the bilateral benefit of HiResolution sound processing and conventional sound processing. [ Time Frame: Various time points post-activation ] [ Designated as safety issue: No ]

Estimated Enrollment:	56
Study Start Date:	October 2004
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator CIS strategy	Device: HiRes 90K Bionic Ear System Cochlear implant system
2: Active Comparator HiRes strategy	Other: HiRes 90K Bionic Ear System Cochlear implant system

Eligibility

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205881

Locations

United States, California
California Ear Institute (Let Them Hear Foundation)
Palo Alto, California, United States, 94303
House Clinic/House Ear Institute
Los Angeles, California, United States, 90057
United States, Florida
University of Miami - Cochlear Implant Center
Miami, Florida, United States, 33136
Tampa Bay Hearing and Balance Center
Tampa, Florida, United States, 33606
United States, Illinois
Carle Clinic Association
Urbana, Illinois, United States, 61801
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49546
United States, Missouri
Midwest Ear Institute
Kansas City, Missouri, United States, 64108
United States, New York
New York University Cochlear Implant Center
New York, New York, United States, 10016
United States, Texas
Dallas Otolaryngology Associates
Dallas, Texas, United States, 75230

Sponsors and Collaborators

Advanced Bionics

Investigators

Study Chair:

Mary Joe Osberger

Advanced Bionics

More Information

No publications provided

Responsible Party:	Advanced Bionics Corporation ( Andrew Quick )
Study ID Numbers:	AUD-BL-070705
Study First Received:	September 13, 2005
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00205881 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Advanced Bionics:

HiResolution Bionic Ear
severe to profound hearing loss
bilateral implantation

Additional relevant MeSH terms:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness
Otorhinolaryngologic Diseases

Nervous System Diseases
Neurologic Manifestations
Hearing Loss
Ear Diseases

ClinicalTrials.gov processed this record on November 25, 2009