RecruitingNot ApplicableNCT05558514

Place-based Cochlear Implant Mapping

Performance Comparisons With Default Versus Place-based Maps


Sponsor

Western University, Canada

Enrollment

30 participants

Start Date

Jun 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The current standard of care approach for programming cochlear implants uses a generalized pitch-map for all patients. This approach fails to account for individualized inner ear anatomy. As a result, many cochlear implant recipients experience place-pitch mismatch. We have recently developed an automated mathematical tool to produce patient-specific, customized cochlear implant pitch-maps (Helpard et al., 2021). In this study, cochlear implant recipients will be randomized to receive either the clinical default pitch-map (the control group) or a place-based pitch-map (the intervention group). Assessments will be conducted at multiple time-intervals to account for patient acclimation and plasticity to both the generalized and individualized pitch-maps. Audiological assessments will be tuned to identify patients' ability to discern pitch scaling and variation in sounds, as well as to understand complexities in speech such as mood and tone. Audiological testing will be conducted in collaboration with the National Centre for Audiology (London, ON) to ensure that the most accurate and relevant metrics are applied.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Adults (18 years of age or older) with moderate-to-profound sensorineural hearing loss bilaterally or single-sided deafness (SSD)
  • Approved by the Cochlear Implant Program at London Health Sciences Centre (LHSC) to undergo unilateral cochlear implantation
  • Identify as a native English speaker (recorded speech recognition/perception materials are presented in English)
  • Deny any cognitive issues
  • Willing and able to participate in study procedures (e.g., unaided testing, speech recognition testing, spatial hearing testing)
  • Willing and able to return for follow-up visits (same intervals as recommended clinically for routine follow-up)

Exclusion Criteria1

  • Fail the Mini Mental State Examination based on their age and education level

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Interventions

OTHERPlace-based cochlear implant mapping

Pre-operative, 3D CT scans of the temporal bone will be uploaded into a deep learning-based tool which automatically resamples, crops, segments, analyzes, and measures the patient's specific cochlear anatomy. These measurements will be input into an individualized pitch mapping function to determine a patient-specific tonotopic distribution of frequencies (place-based map). At device activation (approximately 1 month post-surgery) CIs will be programmed according to the place-based map.

OTHERDefault cochlear implant mapping

At device activation (approximately 1 month post-surgery) CIs will be programmed according to the clinical default program.


Locations(1)

Western University

London, Ontario, Canada

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NCT05558514


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