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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance the hearing experience for people with cochlear implants by developing personalized pitch-maps. Currently, everyone receives the same pitch-map, which can cause mismatches in sound perception. Participants will either continue with the usual map (Default Cochlear Implant Mapping) or try a new, customized one based on their ear's unique structure (Place-based Cochlear Implant Mapping). The trial seeks adults with moderate-to-profound hearing loss who have been approved for a cochlear implant and are willing to follow the study's procedures. The goal is to determine if personalized maps improve users' understanding of speech and sounds compared to the standard approach. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance cochlear implant technology for future users.

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 prior data suggests that this cochlear implant mapping technique is safe?

Research has shown that cochlear implants are generally safe. These devices have helped people with severe hearing loss improve their hearing and speech understanding.

For the specific type of cochlear implant mapping under study, clear safety data from past tests is lacking. However, many patients usually tolerate cochlear implants well. This study examines a new way to adjust the implant's settings to better match each person's ear.

Since this trial is not in its early stages, the treatment is considered safe enough for wider testing. The goal is to determine if this new mapping method can improve hearing without adding any risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the personalized cochlear implant mapping technique because it tailors the device settings to each individual's unique hearing profile, potentially improving outcomes compared to the standard default program. This personalized approach allows users to switch between a place-based map and a default map, offering flexibility and the opportunity to choose the best fit for their hearing needs. By using MED-EL MAESTRO fitting software, this method could significantly enhance auditory performance and user satisfaction, making it a promising advancement in cochlear implant technology.

What evidence suggests that this trial's cochlear implant mappings could be effective for hearing loss?

Research has shown that customizing cochlear implants based on the ear's natural structure can improve hearing for people with hearing loss. In this trial, participants will receive either a Place-based Cochlear Implant Mapping or a Default Cochlear Implant Mapping. Studies have found that individuals with personalized settings understand words and sounds more clearly. This method aligns the device's frequencies with the ear's natural layout, reducing the mismatch common with standard settings. Some research indicates that up to 60% of users experience less sound distortion with this tailored approach. Overall, these findings suggest that this method might offer a clearer and more effective hearing experience. ^{1 2 6 7 8}

Who Is on the Research Team?

Sumit K Agrawal, MD

Principal Investigator

Western University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8787166/

Effectiveness of Place-Based Mapping in Electric-Acoustic ...

Cochlear implant (CI) recipients with hearing preservation in the implanted ear demonstrate significantly improved speech recognition when listening with ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05558514

NCT05558514 | Place-based Cochlear Implant Mapping

... place-based map improves hearing outcomes for cochlear implant recipients. We will compare the auditory abilities, speech recognition and spatial hearing ...

3.

pubs.asha.org

pubs.asha.org/doi/10.1044/2022_AJA-21-00123

Effect of Place-Based Versus Default Mapping Procedures ...

Performance may be improved if the filter frequencies are aligned with the cochlear place frequencies, known as place-based mapping. Performance with default ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33885267/

Effectiveness of Place-based Mapping in Electric-Acoustic ...

Frequency-to-place mismatch of greater than 1/2 octave has been demonstrated in up to 60% of EAS users. Aligning the electric frequency filters via a place- ...

5.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05558514/place-based-cochlear-implant-mapping

Place-based Cochlear Implant Mapping

The primary objective of this study is to evaluate whether a place-based map improves hearing outcomes for cochlear implant recipients. We ...

6.

blog.medel.pro

blog.medel.pro/audiology/cochlear-implantation-outcomes-in-adults-with-unilateral-deafness-speech-perception-tinnitus-sound-localization-and-quality-of-life/

Cochlear Implantation Outcomes in Adults With Unilateral ...

Cochlear implantation in adults with SSD results in significant improvements in speech perception, tinnitus control, sound localization, and QoL [Quality of ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11843266/

Evaluation of Safety and Effectiveness of the LISTENT LCI ...

Cochlear implantation is safe and effective in restoring hearing and speech recognition abilities for individuals with severe to profound sensorineural hearing ...

8.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf/P970051S205B.pdf

Summary of Safety and Effectiveness Data (SSED)

The Cochlear Nucleus 24 Cochlear Implant System is indicated for individuals with unilateral hearing loss who meet the following criteria: • ...