Place-based Cochlear Implant Mapping

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.

Conditions

• Hearing Loss, Sensorineural
• Cochlear Implants

Interventions

OTHER

Place-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.

OTHER

Default cochlear implant mapping

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

Sponsors & Collaborators

• Academic Medical Organization of Southwestern Ontario

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  collaborator OTHER

• Western University, Canada

  lead OTHER

Principal Investigators

• Sumit K Agrawal, MD · Western University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-07

Primary Completion

2026-05-31

Completion

2026-05-31

Countries

• Canada

Study Locations