Clinical trial NCT02331017: Assessment of Bimodal Contribution in Adult Cochlear Implant Users
Official 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deafness
Keywords: Bimodal
Cochlear Implant
Hearing aid
Auditory Perception
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

-

Primary outcomes:
measure: Speech perception task specific tests using assessment protocol which will include 6 speech perception tests in quiet and noise listening conditions.
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of functional performance in daily life using self-repot questionnaires
timeFrame: 12 months
measure: Standard basic speech perception tests
timeFrame: 12 Months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
affiliation: Bnai Zion Medica Center
name: Michal Luntz, MD
role: PRINCIPAL_INVESTIGATOR
References: