Personalized Cochlear Implant Mapping for Hearing Loss

Overseen By Sumit K Agrawal, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Cognitive issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6 months

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Personalized Cochlear Implant Mapping for Hearing Loss?

Research shows that place-based cochlear implant mapping, which aligns the frequencies with the natural position of the cochlea, can improve speech understanding in both quiet and noisy environments compared to default mapping. This suggests that personalized mapping may help users hear better by reducing mismatches between the implant and the ear's natural hearing structure. ^{1 2 3 4 5}

Is personalized cochlear implant mapping safe for humans?

Research on cochlear implants, including studies on their safety and reliability, suggests that there are established protocols to evaluate the safety of these devices. While specific safety data for personalized mapping isn't detailed, general safety evaluation frameworks for cochlear implants exist, indicating a focus on ensuring safe and reliable use in humans. ^{6 7 8 9 10}

How does Place-based Cochlear Implant Mapping differ from other treatments for hearing loss?

Place-based Cochlear Implant Mapping is unique because it aligns the electric signals from the implant with the natural frequency locations in the cochlea, which can improve speech recognition compared to traditional methods that may not match these frequencies as closely. This personalized approach considers individual differences in electrode placement and cochlear structure, potentially leading to better hearing outcomes. ^{4 5 11 12 13}

Research Team

Sumit K Agrawal, MD

Principal Investigator

Western University

Eligibility Criteria

This trial is for adults over 18 with moderate-to-profound sensorineural hearing loss or single-sided deafness, who are native English speakers and approved for cochlear implantation. Participants must be able to do study tasks and return for follow-ups. Those with cognitive issues or failing a mental state exam are excluded.

Inclusion Criteria

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

I can attend all follow-up visits as recommended.

I am a native English speaker.

Exclusion Criteria

I did not pass a mental fitness test appropriate for my age and education.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Activation

Participants undergo cochlear implant surgery and initial device activation

1 month

1 visit (in-person)

Treatment

Participants receive either the default or place-based pitch-map and undergo audiological assessments

6 months

4 visits (in-person) at 1, 3, 6, and 7 months post-activation

Crossover and Final Assessment

Participants switch to the alternative map for 1 month and choose their preferred map for final assessment

1 month

1 visit (in-person) at 7 months post-activation

Follow-up

Participants are monitored for long-term outcomes and audiological performance

1 year

1 visit (in-person) at 1 year post-activation

Treatment Details

Interventions

• Default Cochlear Implant Mapping
• Place-based Cochlear Implant Mapping

Trial Overview The study compares two methods of programming cochlear implants: the standard generalized pitch-map versus a new patient-specific place-based pitch-map. Patients will be randomly assigned to one of these approaches and tested over time on their ability to recognize pitches and understand speech nuances.

Participant Groups

Group I: Place-based map Experimental Treatment 1 Intervention

CIs will be mapped according to each participant's unique place-based map using MED-EL MAESTRO fitting software. Participants' audiological performance will be assessed in both the experimental and default programs at activation and at 6 months. At 1-month and 3-month visits, performance will be assessed in the participant's assigned program only. Following the 6-month testing interval, participants will listen to the alternative map than the one they were assigned for 1 additional month. At the 7-month visit, participants will be assessed in both programs. After the 7-month visit, participants will be given the choice to move forward with whichever map they prefer. The final assessment interval will take place at 1-year in the participant's chosen map.

Group II: Default map Active Control 1 Intervention

CIs will be mapped according to the clinical default program using MED-EL MAESTRO fitting software. Participants' audiological performance will be assessed in both the experimental and default programs at activation and at 6 months. At 1-month and 3-month visits, performance will be assessed in the participant's assigned program only. Following the 6-month testing interval, participants will listen to the alternative map for 1 additional month from the one they were randomly assigned. At the 7-month visit, participants will be assessed in both programs. After the 7-month visit, participants will be given the choice to move forward with whichever map they prefer. The final assessment interval will take place at 1-year in the participant's chosen map.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

Academic Medical Organization of Southwestern Ontario

Collaborator

Trials

17

Recruited

1,600+

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

Collaborator

Trials

686

Recruited

427,000+

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

Collaborator

Trials

668

Recruited

424,000+

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

Collaborator

Trials

678

Recruited

421,000+

Lawson Health Research Institute

Collaborator

Trials

684

Recruited

432,000+

Findings from Research

This study introduces a new evaluation protocol for research platforms (RPs) used in cochlear implants (CIs) and hearing aids (HAs) to ensure their operational safety and reliability, which is crucial for advancing hearing restoration technologies.

The proposed two-phase analysis includes an acoustic phase to assess sound output safety and a parameter phase to evaluate the reliability of electrical stimulation, providing a structured approach to improve the design and testing of hearing devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation framework for research platforms to advance cochlear implant/hearing aid technology: A case study with CCi-MOBILE. Shekar, RCMC., Hansen, JHL.[2022]

The study analyzed 269 complications related to osseointegrated auditory implants (OAIs) from the MAUDE database, revealing that the majority of complications were implant-related (145 cases), but the database may not accurately represent the true incidence of complications.

The findings indicate that the MAUDE database has limitations in its design and reporting quality, suggesting a need for a better central registry to track complications associated with otologic implants and to facilitate further research into their causes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Utility of the MAUDE Database for Osseointegrated Auditory Implants. Coelho, DH., Tampio, AJ.[2017]

The study analyzed the electrode array positions of 11 pediatric and adult auditory brainstem implant (ABI) users using postoperative imaging, revealing significant variability in array orientation that may affect auditory performance.

Differences in electrode array angles and positions were linked to variations in electrical thresholds and the number of active electrodes, suggesting that precise positioning of the ABI could be crucial for optimizing sound perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory Brainstem Implant Array Position Varies Widely Among Adult and Pediatric Patients and Is Associated With Perception. Barber, SR., Kozin, ED., Remenschneider, AK., et al.[2018]

A retrospective analysis of cochlear implant adverse events over a 10-year period revealed a significant increase in cases with multiple or unknown causes, particularly gradual idiopathic loss of performance, indicating a shift in the nature of reported issues.

Despite improvements in manufacturing and surgical techniques, the rise in complex adverse events suggests a need for further research to understand and address these idiopathic cases to enhance cochlear implant outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in cochlear implant complications: implications for improving long-term outcomes. Causon, A., Verschuur, C., Newman, TA.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

Neural response imaging (NRI) cochlear mapping: prospects for clinical application. [2007]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Using Anatomy-Based Fitting to Reduce Frequency-to-Place Mismatch in Experienced Bilateral Cochlear Implant Users: A Promising Concept. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

Pediatric cochlear implant fitting parameters in inner ear malformation: Is it same with normal cochlea? [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Imaging-based frequency mapping for cochlear implants - Evaluated using a daily randomized controlled trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Place-Based Versus Default Mapping Procedures on Masked Speech Recognition: Simulations of Cochlear Implant Alone and Electric-Acoustic Stimulation. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

An evaluation framework for research platforms to advance cochlear implant/hearing aid technology: A case study with CCi-MOBILE. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Utility of the MAUDE Database for Osseointegrated Auditory Implants. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Rates of revision and device failure in cochlear implant surgery: a 30-year experience. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Auditory Brainstem Implant Array Position Varies Widely Among Adult and Pediatric Patients and Is Associated With Perception. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Trends in cochlear implant complications: implications for improving long-term outcomes. [2013]

11. England pubmed.ncbi.nlm.nih.gov

Scalar localisation of peri-modiolar electrodes and speech perception outcomes. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Frequency-place compression and expansion in cochlear implant listeners. [2019]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of Two Place-Based Mapping Procedures on Masked Sentence Recognition as a Function of Electrode Array Angular Insertion Depth and Presence of Acoustic Low-Frequency Information: A Simulation Study. [2023]