Place-based Cochlear Implant Mapping

Last updated: March 24, 2025
Sponsor: Western University, Canada
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hearing Impairment

Hearing Loss

Deafness

Treatment

Place-based cochlear implant mapping

Default cochlear implant mapping

Clinical Study ID

NCT05558514
119978
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Adults (18 years of age or older) with moderate-to-profound sensorineural hearingloss bilaterally or single-sided deafness (SSD)

  • Approved by the Cochlear Implant Program at London Health Sciences Centre (LHSC) toundergo unilateral cochlear implantation

  • Identify as a native English speaker (recorded speech recognition/perceptionmaterials are presented in English)

  • Deny any cognitive issues

  • Willing and able to participate in study procedures (e.g., unaided testing, speechrecognition testing, spatial hearing testing)

  • Willing and able to return for follow-up visits (same intervals as recommendedclinically for routine follow-up)

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Place-based cochlear implant mapping
Phase:
Study Start date:
June 07, 2023
Estimated Completion Date:
May 31, 2026

Study Description

The cochlea is a spiral-shaped organ of hearing within the inner ear where acoustic vibrations are decomposed into different frequencies to create electrical signals that transmit audio information to the brain. The basilar membrane (BM), which is an internal soft tissue component of the cochlea, mechanically filters different frequencies at different distances along the helical shape. This separation is what allows us to discern different pitches in sound. Due to individual anatomical differences, each person naturally has their own unique pitch-map, or tonotopic map, that maps nerves at specific locations along the basilar membrane to perceived frequencies in the brain.

When the cochlea is not functioning properly, cochlear implantation is a successful treatment to restore the sense of sound. A cochlear implant (CI) is a neural-prosthetic device that consists of an external portion that sits behind the ear and a surgically implanted array of electrodes inserted along the cochlea. After surgery, implants are programmed using a process called pitch mapping, whereby each implanted electrode is assigned a specific stimulation frequency. A CI must span the entire length of the cochlea and stimulate with the correct pitch-map (meaning the correct nerves and locations are stimulated with the correct frequencies) to produce full and accurate hearing. When a generalized pitch-mapping approach is used, each electrode within a CI array will stimulate with a pre-specified frequency, independent of a patient's individual tonotopy or postoperative electrode location. Generalized pitch-mapping can result in a place-pitch mismatch of over one octave. This mismatch inhibits the pitch perception required for complex hearing tasks, such as music appreciation or speech recognition. Neural plasticity can allow auditory perception to adapt over time to reduce the effect of cochlear implant pitch-map errors, however this requires long periods of acclimation, is dependent on recipient age and environment, and can only overcome certain sized pitch-map errors. Customization of CI pitch-maps can reduce rehabilitation time and the need for implant acclimation.

Patient-specific pitch maps are produced by accurately determining each patient's cochlear duct length (CDL), or more specifically BM length, from diagnostic images. Previous methods to determine CDL have traditionally contained uncertainties at the start- and end-point of the BM, largely due to visualization limitations in the imaging modality used. Measuring an inaccurate BM length may cause an erroneous shift in all tonotopic frequencies. Using an enhanced imaging technique, our team has recently developed an algorithm to automatically and accurately estimate CDL, segment the BM, and determine CI electrode locations from individual patient computed-tomography (CT) scans to produce customized CI pitch-maps, called placed-based mapping (Helpard et al., 2021).

The primary objective of this study is to evaluate whether a place-based map improves hearing outcomes for cochlear implant recipients. We will compare the auditory abilities, speech recognition and spatial hearing (speech recognition in spatially separated noise, and sound source localization) for subjects randomized to listen exclusively with a default map versus our novel place-based map. We hypothesize that the majority of CI recipients will experience a faster rate of speech recognition and spatial hearing growth when their cochlear implant is mapped to match the electric stimulation with the tonotopic place frequency (i.e., using the place-based map).

Connect with a study center

  • Western University

    London, Ontario N6A 3K7
    Canada

    Active - Recruiting

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