Hearing Loss Clinical Trial
Official title:
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
Verified date | May 2017 |
Source | Bnai Zion Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | June 15, 2019 |
Est. primary completion date | April 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Two groups, ideally each of 20 experienced adult bimodal users will be studied: one Arabic speaking and the other Hebrew speaking. B. Inclusion criteria: - 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. Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bnai Zion Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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