Combined Acoustic and Electric Hearing (CI/HA) in Adult Bimodal Users Using a HA With a Bimodal Fitting Formula
Assessment of the Contribution of Combined Acoustic Hearing Via a Hearing Aid and Electric Hearing Via a Cochlear Implant in Adult Bimodal Users Following Using a HA With a Dedicated Bimodal Fitting Formula
1 other identifier
observational
40
0 countries
N/A
Brief Summary
Introduction: Bilateral-bimodal users may benefit from bilateral-binaural and a bimodal effect . The two modes of stimulation complement each other and may overcome the limitation of electric hearing alone. However, alongside the expected benefits of having two hearing systems in bilateral bimodal hearing, there are several inherent mismatches in combing two different stimulation methods, which may negatively impact the processing of the binaural cues. Aim: To determine whether bimodal listening with a hearing aid programmed using a dedicated bimodal fitting formula, which aligns the frequency response, loudness growth functions, and automatic gain control (AGC) characteristics between the cochlear implant speech processor and the hearing aid brings additional benefit over bimodal listening with the subject's clinical hearing instrument via the use of using a comprehensive battery of speech perception tests aimed at different aspects of binaural hearing as well as the contribution of the unique bimodal complementary effect. A secondary goal is to identify the tests that are best suited to predicting and evaluating bimodal benefit. Method: The study will include 20 Hebrew and 20 Arabic speakers' adult bilateral-bimodal users that their audiometric thresholds in the non implanted ear will be no worse than 75 dB HL at 250 and 85 dB HL at 500 Hz, who use their hearing aids for at least 75% of their waking hours. The added benefit of the hearing aid programmed using a dedicated bimodal fitting formula will be evaluated using six task-specific tests designed to sensitively assess the bilateral-binaural and bimodal complementary effects using roving speech and noise and different types of background noises (maskers), pitch-related task and subjective questionnaire. Participants will be tested twice in quick succession, at two-weekly intervals, in establishing a baseline score with their clinical HAs. Then participants will be tested again twice in quick succession, at two-weekly intervals following three month experience with the HA fitted with the bimodal fitting formula. All tests will be administered the CI/HA listening condition.
Trial Health
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participants targeted
Target at P25-P50 for all trials
Started Jun 2017
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2017
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedStudy Start
First participant enrolled
June 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2019
CompletedMay 5, 2017
May 1, 2017
1.8 years
February 19, 2017
May 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
outcome measure: the speech perception test battery and questionnaire scores will be calculated as follows: [(CI+ HA (old version)] - [ CI+HA (new dedicated prescription)].
The added benefit of the hearing aid programmed using a dedicated bimodal fitting formula will be evaluated using six task-specific tests designed to sensitively assess the bilateral-binaural and bimodal complementary effects using roving speech and noise and different types of background noises (maskers), pitch-related task and subjective questionnaire. Participants will be tested twice in quick succession, at two-weekly intervals, in establishing a baseline score with their clinical HAs. Then participants will be tested again twice in quick succession, at two-weekly intervals following three month experience with the HA fitted with the bimodal fitting formula. All tests will be administered in the CI/HA listening condition. Comparison between these test results will estimate the added benefit of the dedicated bimodal formula.
about 2 months
Study Arms (2)
Hebrew speaking participants
Hebrew speaking bilateral-bimodal users will be assessed using cochlear implants and hearing aids
Arabic speaking participants
Arabic speaking bilateral-bimodal users will be assessed using cochlear implants and hearing aids
Interventions
speech perception tests and bimodal fitting
Eligibility Criteria
The study will include 20 Hebrew and 20 Arabic speakers' adult bilateral-bimodal users that their audiometric thresholds in the non implanted ear will be no worse than 75 dB HL at 250 and 85 dB HL at 500 Hz, who use their hearing aids for at least 75% of their waking hours.
You may qualify if:
- Two groups, ideally each of 20 experienced adult bimodal users will be studied: one Arabic speaking and the other Hebrew speaking.
- Regular adults bimodal users (at least 18 years of age) having continuous use of both CI and hearing instrument for 75% of waking hours.
- Their audiometric thresholds in the non implanted ear will be no worse than 75 dB HL at 250 and 85 dB HL at 500 Hz.
- All participants will have stable CI map and acquired at least twelve month's experience using a CI and HA in combination using the Naida CI sound processor
- Participants will be first language speakers of either Arabic or Hebrew
- Participants will be required to demonstrate highly reliable responses, and will be able to understand recorded speech material in the presence of competing noise, achieving at least 50% correct for sentences when the signal-to-noise-ratio is +20 dB.
- No participant shall have any additional physical or cognitive problem that might interfere with their ability to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
February 19, 2017
First Posted
May 5, 2017
Study Start
June 15, 2017
Primary Completion
April 1, 2019
Study Completion
June 15, 2019
Last Updated
May 5, 2017
Record last verified: 2017-05