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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT02331017
Date of registration: 24/12/2014
Prospective Registration: No
Primary sponsor: Bnai Zion Medical Center
Public title: Assessment of Bimodal Contribution in Adult Cochlear Implant Users
Scientific title: Assessment of the Contribution of the Combined Acoustic Hearing Via a Hearing Aid and Electric Hearing Via a Cochlear Implant in Adult Bimodal Users With Moderate to Severe Residual Hearing in the Implanted and Non Implanted Ear.
Date of first enrolment: December 2014
Target sample size: 20
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT02331017
Study type:  Interventional
Study design:  Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Israel
Contacts
Name:     Michal Luntz, MD
Address: 
Telephone: 97248359544
Email: michal.luntz@b-zion.org.il
Affiliation: 
Name:     Talma Shpak, PhD
Address: 
Telephone: 97248359544
Email: talma.shpak@b-zion.org.il
Affiliation: 
Name:     Michal Luntz, MD
Address: 
Telephone:
Email:
Affiliation:  Bnai Zion Medica Center
Key inclusion & exclusion criteria

Inclusion Criteria:

- Bilateral-bimodal users

- With moderate-to-severe hearing loss at 250 Hz, 500 Hz and 1000 Hz in the
non-implanted ear

- Who use hearing aids for at least 75% of their waking hours

Exclusion Criteria:

-



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Deafness
Intervention(s)
Behavioral: Speech perception tests and self-rating questionnaire
Primary Outcome(s)
Speech perception task specific tests using assessment protocol which will include 6 speech perception tests in quiet and noise listening conditions. [Time Frame: 12 months]
Secondary Outcome(s)
Standard basic speech perception tests [Time Frame: 12 Months]
Assessment of functional performance in daily life using self-repot questionnaires [Time Frame: 12 months]
Secondary ID(s)
BZ0084
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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