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Combined Acoustic and Electric Hearing (CI/HA) in Adult Bimodal Users Using a HA With a Bimodal Fitting Formula

NCT03142100 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2017-05-05

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

cochlear implants and hearing aids

speech perception tests and bimodal fitting

Sponsors & Collaborators

  • Bnai Zion Medical Center

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-15
Primary Completion
2019-04-01
Completion
2019-06-15
FDA Device
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03142100 on ClinicalTrials.gov