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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 19, 2008

Start Date ^ICMJE

October 2004

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

The study will evaluate bilateral vs. unilateral benefit in adults with two Bionic ears.
The study will assess the bilateral benefit of HiResolution sound processing and conventional sound processing.

Change History

Complete list of historical versions of study NCT00205881 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not applicable

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Hearing Loss

Intervention ^ICMJE

Device: HiRes 90K Bionic Ear System
Other: HiRes 90K Bionic Ear System

Study Arms / Comparison Groups

Active Comparator: CIS strategy
Active Comparator: HiRes strategy

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2009

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00205881

Responsible Party

Andrew Quick, Advanced Bionics Corporation

Study ID Numbers ^ICMJE

AUD-BL-070705

Study Sponsor ^ICMJE

Advanced Bionics

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Mary Joe Osberger

Advanced Bionics

Information Provided By

Advanced Bionics

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP