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Evaluating hearing performance with cochlear implants within the same patient using daily randomization and

L J G Lambriks1, M van Hoof2, J A Debruyne2

  • 1Department of ENT/Audiology, School for Mental Health and Neuroscience (MHeNs), Maastricht University Medical Center, Maastricht, The Netherlands. lars.lambriks@mumc.nl.

Trials
|June 25, 2020
PubMed
Summary
This summary is machine-generated.

This study introduces a novel daily randomized clinical trial design for cochlear implant (CI) fitting. This approach aims to overcome sample size limitations and evaluate individualized tonotopical CI fitting strategies.

Keywords:
Bimodal hearingCochlear implantDaily randomizationImaging based fittingTonotopy

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Area of Science:

  • Audiology
  • Neurosurgery
  • Biomedical Engineering

Background:

  • Prospective cochlear implant (CI) research faces challenges with small sample sizes and methodological limitations.
  • The ELEPHANT study proposes an innovative daily randomized clinical trial design for evaluating CI fitting.
  • This design addresses limitations in current research methodologies for CI studies.

Purpose of the Study:

  • To evaluate an imaging-based CI mapping strategy using a daily randomized approach.
  • To assess the effectiveness of individualized tonotopical fitting in cochlear implant recipients.
  • To determine if the novel trial design can overcome sample size and carryover effect issues.

Main Methods:

  • A single-blinded, daily-randomized crossover trial involving a minimum of 20 participants.
  • Utilizing post-operative cone beam CT scans (CBCT) for imaging-based mapping of electrical input to the cochlea.
  • Participants act as their own controls, daily switching between experimental and standard fitting programs.

Main Results:

  • The study hypothesizes that the experimental fitting strategy will lead to a steeper learning curve.
  • Anticipated outcomes include improved performance in challenging listening scenarios and enhanced sound quality.
  • The strategy is expected to better complement residual hearing and be preferred by CI recipients.

Conclusions:

  • The novel daily randomized trial design offers a viable alternative for CI research.
  • The experimental fitting strategy shows promise for improving CI outcomes and recipient satisfaction.
  • Further investigation into the suitability of this trial design for CI research is warranted.