An Approach for Individualized Cochlear Frequency Mapping Determined From 3D Synchrotron Radiation Phase-Contrast Imaging.
Luke Helpard, Hao Li, Seyed A Rohani...
https://pubmed.ncbi.nlm.nih.gov/33983877Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05558514
Performance Comparisons With Default Versus Place-based Cochlear Implant Maps to Improve Hearing Outcomes
Led by Western University, Canada · Updated on 2025-03-28
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Western University, Canada
Lead Sponsor
A
Academic Medical Organization of Southwestern Ontario
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new method for programming cochlear implants to better match the unique inner ear anatomy of each patient. This study compares the standard, generalized pitch-map used for all patients with a customized place-based pitch-map designed for individual cochlear structures. The goal is to see if the place-based map improves hearing outcomes such as speech recognition and spatial hearing in adults with sensorineural hearing loss or single-sided deafness. Participants will be randomly assigned to receive either the default clinical pitch-map or the place-based pitch-map, both programmed using MED-EL MAESTRO fitting software. Testing occurs at device activation (about one month after surgery) and at 1, 3, 6, 7 months, and 1 year post-activation. After six months, participants will try the alternative map for one month before choosing their preferred map to continue using until the final assessment at one year. During the study, participants will undergo various audiological assessments to measure their ability to recognize speech sounds, discern pitch variations, and localize sounds. Tests include word and vowel recognition, sentence understanding, sound quality, and spatial hearing questionnaires. Follow-up visits align with clinical schedules, and researchers will monitor changes in hearing performance over time to assess the impact of the customized mapping approach.
CONDITIONS
Brief Title
Place-based Cochlear Implant Mapping
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older with moderate-to-profound sensorineural hearing loss in both ears or single-sided deafness
- Approved by the Cochlear Implant Program at London Health Sciences Centre to undergo unilateral cochlear implantation
- Identify as a native English speaker
- No cognitive issues
- Willing and able to participate in study procedures including unaided testing, speech recognition testing, and spatial hearing testing
- Willing and able to return for follow-up visits at clinically recommended intervals
You will not qualify if you...
- Fail the Mini Mental State Examination based on age and education level
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 7 months post-implant activation
Participants undergo cochlear implantation surgery, then approximately 1 month post-surgery their cochlear implants will be programmed with either a place-based map or a default map. Audiological performance is assessed at activation and over the following months as participants use their assigned maps.
Visits at device activation (~1 month post-surgery), and at 1 month, 3 months, 6 months, and 7 months post-activation
Follow-up
Duration - Up to 1 year post-implant activation
After the 7-month visit, participants choose which cochlear implant map to continue using. Final hearing assessments are conducted at 1 year post-activation to evaluate long-term outcomes with the chosen map.
1 visit at 1 year post-activation
Trial Site Locations
Total: 1 location
1
Western University
London, Ontario, Canada, N6A 3K7
Actively Recruiting
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Research Team
S
Sumit K Agrawal, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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