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

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

Genetics Home Reference related topics:

nonsyndromic deafness

MedlinePlus related topics:

Hearing Disorders and Deafness

U.S. FDA Resources

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

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

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