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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Advanced Bionics
ClinicalTrials.gov Identifier:
NCT00205881
First received: September 13, 2005
Last updated: February 28, 2012
Last verified: February 2012

September 13, 2005
February 28, 2012
October 2004
May 2009   (final data collection date for primary outcome measure)
Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users. [ Time Frame: 8 months of bilateral cochlear implant use ] [ Designated as safety issue: Yes ]
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.
  • 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.
Complete list of historical versions of study NCT00205881 on ClinicalTrials.gov Archive Site
HINT Sentences in Noise [ Time Frame: 8 months of bilateral cochlear implant use ] [ Designated as safety issue: No ]
20 sentences presented in noise at fixed levels
Not Provided
Not Provided
Not Provided
 
Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System
Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hearing Loss
Device: HiRes 90K Bionic Ear System
Cochlear implant system
Active Comparator: 1
Bilaterally Implanted with HiRes 90K device.
Intervention: Device: HiRes 90K Bionic Ear System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. No previous implant experience.
  2. Age 18 years or older.
  3. Postlingual onset of hearing loss.
  4. Sensorineural hearing loss of a severe or greater degree in both ears.
  5. Normal/patent cochlear anatomy in each ear.
  6. English language proficiency.
  7. Willingness and ability to participate in all scheduled procedures.

Exclusion Criteria:

No exclusion criteria specified, except for the opposite of inclusion criteria listed above.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00205881
AUD-BL-070705
No
Advanced Bionics
Advanced Bionics
Not Provided
Study Chair: Mary Joe Osberger Advanced Bionics
Advanced Bionics
February 2012

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