Assessment of Bimodal Contribution in Adult Cochlear Implant Users

NCT ID: NCT02331017

Last Updated: 2015-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-12-31

Brief Summary

To evaluate the combination of electric hearing through Cochlear Implant and acoustic hearing through hearing aid in bimodal users with moderate-to-severe hearing loss in the non-implanted ear. The research will also provide pilot study data on unilateral Cochlear Implant recipients with residual useful acoustic hearing in the implanted ear whose acoustic hearing has been preserved.

Detailed Description

Many current unilateral Cochlear Implant users have some residual acoustic hearing in the opposite ear as well as in the implanted ear. The amount of useful residual acoustic hearing varies among these implantees. There are several acoustic and electric combinations in the bilateral-bimodal listening mode depending on the amount of useful residual acoustic hearing in each ear. The combination of low frequency acoustic information provided by the hearing aid on each ear, completes the high frequency electric information provided by the Cochlear Implant (complementary bimodal benefit). Each of the different rehabilitation combinationsfor unilateral Cochlear Implant users enablesa unique integration of the three aspects of bilateral hearing bilaterality, binaurality and bimodality which may provide significant advantages over unilateral Cochlear Implant stimulation in terms of speech perception in noise, complementary information as well as localization abilities.

The study will include 20 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. Evaluation utilizes bilateral-binaural and bimodal complementary effects task-specific test batteries based on published doctoral research project. The assessment protocol consisted of tests that include various speech materials, different maskers, presentation of the noise from different locations in space, right/left speech lateralization, pitch-related tasks and subjective questionnaires. All tests will be administered in three listening conditions: Cochlear Implant -alone, hearing aid-alone and Cochlear Implant +hearing aid.

Conditions

Deafness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bimodal users

Bilateral-bimodal users with moderate-to-severe hearing loss who use hearing aids for at least 75% of their waking hours.

Administration of Speech perception tests and self-rating questionnaire

Group Type: EXPERIMENTAL

Speech perception tests and self-rating questionnaire

Intervention Type: BEHAVIORAL

Speech perception test results and self-rating questionnaire scores will be analyzed by means of non-parametric statistical tests. The statistical tests will be chosen in accordance with the number and type of variables in each test. Correlation between audiological variables (aided and unaided hearing thresholds in the non implanted ear, aided speech perception abilities in the HA-alone condition) and the bilateral-bimodal benefit will be examined. Moreover, possible relationship between self-rating questionnaire scores and speech perception test results will be assessed.

Interventions

Speech perception tests and self-rating questionnaire

Speech perception test results and self-rating questionnaire scores will be analyzed by means of non-parametric statistical tests. The statistical tests will be chosen in accordance with the number and type of variables in each test. Correlation between audiological variables (aided and unaided hearing thresholds in the non implanted ear, aided speech perception abilities in the HA-alone condition) and the bilateral-bimodal benefit will be examined. Moreover, possible relationship between self-rating questionnaire scores and speech perception test results will be assessed.

Intervention Type: BEHAVIORAL

Eligibility 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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

MICHAL.LUNTZ

Head of the Otolaryngology Head and Neck Surgery Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michal Luntz, MD

Role: PRINCIPAL_INVESTIGATOR

Bnai Zion Medica Center

Locations

Bnai Zion Medical Center

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Michal Luntz, MD

Role: CONTACT

michal.luntz@b-zion.org.il

97248359544

Noam Yehudai, MD

Role: CONTACT

noam.yehudai@b-zion.org.il

97248359544

Facility Contacts

Talma Shpak, PhD

Role: primary

talma.shpak@b-zion.org.il

97248359544

Other Identifiers

BZ0084

Identifier Type: -

Identifier Source: org_study_id