Cochlear Implant Programming for Unilateral Hearing Loss

Enrolling by invitation at 2 trial locations

Overseen By Ivy Chen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Med-El Corporation

Disqualifiers: Bilateral cochlear implants, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different settings on cochlear implants to assess their impact on hearing performance in individuals with hearing loss in one ear. The focus is on adjusting the audio processor's frequency settings using both standard and new experimental methods. Participants should be candidates for a cochlear implant, have normal to moderately severe hearing loss in one ear, and use a MED-EL cochlear implant. This study suits those who have recently started using their cochlear implant and wish to fine-tune their hearing experience. As an unphased trial, it offers participants the opportunity to explore innovative ways to enhance their hearing.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does require that participants with moderate hearing loss in the opposite ear continue using a hearing aid.

What prior data suggests that this programming of cochlear implant audio processor frequency settings is safe?

Research has shown that adjusting cochlear implants based on individual anatomy is generally well-received. Studies indicate that this approach can help users hear speech better in both quiet and noisy settings. While these studies don't detail specific side effects, the focus on enhancing hearing suggests safety. This method involves no new medication or surgery; it simply fine-tunes the implant to better match a person's anatomy. Consequently, safety concerns are likely minimal, centering mainly on adjusting the device for improved hearing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these new cochlear implant programming methods for unilateral hearing loss because they offer a personalized approach that could enhance hearing outcomes. Unlike standard programming, which uses default frequency settings, the experimental anatomy-based fittings tailor the audio processor settings based on each individual's unique anatomical data from post-operative imaging. This customization aims to optimize the cochlear implant's performance, potentially providing clearer and more natural hearing experiences for patients. By leveraging personal anatomical details, these experimental methods could significantly improve the precision of cochlear implant programming compared to traditional techniques.

What evidence suggests that this trial's programming of cochlear implant audio processor frequency settings could be effective for unilateral hearing loss?

This trial will compare different programming approaches for cochlear implants in individuals with unilateral hearing loss. Research has shown that adjusting cochlear implants based on a person's unique ear structure can greatly improve hearing in noisy environments for those with hearing loss in one ear. Studies have found that this personalized approach helps users hear better in challenging listening situations and enhances binaural hearing. People who have tried this method often prefer it over traditional approaches because it improves their ability to understand speech and enhances their overall hearing experience. These findings suggest that personalized fitting could make cochlear implants more effective for those with hearing loss in one ear. ^{3 4 5 6 7}

Who Is on the Research Team?

Katelyn Glassman, AuD

Principal Investigator

Med-El Corporation

Are You a Good Fit for This Trial?

This trial is for individuals with hearing loss ranging from deafness in one ear to sensorineural hearing loss, who have recently received a cochlear implant. They should have normal to moderately severe hearing in the other ear.

Inclusion Criteria

The ear to be implanted, acoustic hearing thresholds must be no better than 50 dBHL at 250 Hz and 65 dBHL at 500 Hz

English is the primary language

My post-surgery CT scan is suitable for OTOPLAN analysis.

Exclusion Criteria

Subjects who receive a cochlear implant in the contralateral ear prior to the 12-month interval

Subjects who do not meet one or more of the above-mentioned inclusion criteria are excluded from the study

Subjects required to use a hearing aid per inclusion criteria who stop use of a hearing aid in the contralateral ear will be withdrawn at the time of discontinued hearing aid use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants are randomized into a starting frequency setting at device activation or shortly after for the first three months of device use

3 months

Secondary Treatment

Participants are randomized into different frequency settings and tested before and after a period of listening experience

4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 months

What Are the Treatments Tested in This Trial?

Interventions

• Programming of cochlear implant audio processor frequency settings

Trial Overview The study is testing how different frequency settings on the audio processor of a cochlear implant affect the user's performance. It focuses on those using electric-only stimulation in their implanted ear.

How Is the Trial Designed?

Group I: Experimental Anatomy-Based Fitting 2 Experimental Treatment 1 Intervention

The audio processor frequency setting will be programmed with experimental settings for anatomy-based fitting using individual anatomical information obtained from analysis of post-operative imaging.

Group II: Experimental Anatomy-Based Fitting 1 Experimental Treatment 1 Intervention

The audio processor frequency setting will be programmed using experimental settings for anatomy-based fitting using individual anatomical information obtained from analysis of post-operative imaging.

Group III: Default Clinical Frequency Setting Active Control 1 Intervention

The audio processor frequency setting will be programmed based on current frequency defaults in the clinical programming software

Group IV: Default Anatomy-Based Fitting Active Control 1 Intervention

The audio processor frequency setting will be programmed based on current anatomy-based fitting frequency defaults in the clinical programming software

Who Is Running the Clinical Trial?

Med-El Corporation

Lead Sponsor

Trials

27

Recruited

2,100+

Published Research Related to This Trial

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]

Cochlear implants (CI) significantly improved cortical auditory evoked potentials (CAEP) and auditory performance in adults with unilateral hearing loss, showing the greatest impact compared to other rehabilitation systems like CROS and BAHA.

The study found that CI enhanced speech understanding in challenging listening conditions, indicating its effectiveness in improving auditory processing and performance for individuals with unilateral hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortical auditory responses according to hearing rehabilitation in unilateral hearing loss. Legris, E., Roux, S., Aoustin, JM., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39299967/

Anatomy-based fitting improves speech perception in noise ... Anatomy-based fitting improves speech perception in noise for cochlear implant recipients with single-sided deafness ... Hearing Loss, Unilateral ...

2. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2022.786939/full

The Effectiveness of Unilateral Cochlear Implantation on ... This study demonstrates significant benefits of cochlear implantation in the performance-based and patient-reported outcomes in an unselected patient sample.

3. mdpi.com mdpi.com/2075-4426/13/7/1109

Using Anatomy-Based Fitting to Reduce Frequency ... ABF mapping may be an effective tool for compensating the frequency-to-place mismatch in experienced bilateral CI users.

4. link.springer.com link.springer.com/article/10.1007/s00405-024-08984-4

Anatomy-based fitting improves speech perception in noise ... Experienced SSD CI users preferred using the ABF map, which gave them significant improvements in binaural hearing and some aspects of speech perception.

5. researchgate.net researchgate.net/publication/365909279_One_Click_Is_Not_Enough_Anatomy-Based_Fitting_in_Experienced_Cochlear_Implant_Users

Anatomy-Based Fitting in Experienced Cochlear Implant ... Purpose The aim of this prospective study was to compare the results of the traditional cochlear implant fitting method and the anatomy-based ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06734039

Impact of Anatomy-Based Cochlear Implant Programming ... The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users.

7. withpower.com withpower.com/trial/cochlear-implant-programming-for-unilateral-hearing-loss-0cd80

Cochlear Implant Programming for Unilateral Hearing Loss The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users ...