Cochlear Implant Programming for Unilateral Hearing Loss

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

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Programming of cochlear implant audio processor frequency settings for Unilateral Hearing Loss?

Research shows that cochlear implants can improve hearing by providing access to sound, which helps the brain process speech and environmental sounds. Studies indicate that cochlear implants are effective in improving speech recognition and auditory performance, even in cases of long-term hearing loss. ^{1 2 3 4 5}

Is cochlear implant programming safe for humans?

Research shows that cochlear implants, including their programming, have been evaluated for safety and reliability. A study developed a protocol to assess the safety of cochlear implant systems, ensuring that the electrical stimulation they provide is safe for users. ^{1 6 7 8 9}

How does cochlear implant programming for unilateral hearing loss differ from other treatments?

This treatment is unique because it involves programming the cochlear implant to optimize frequency settings, which can improve music perception and auditory performance, unlike traditional hearing aids or other devices that may not address these specific needs. ^{1 10 11 12 13}

What is the purpose of this trial?

The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users using electric-only stimulation in the implanted ear with normal hearing to moderately severe hearing loss in the opposite ear.

Eligibility Criteria

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

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

Minimum of 10 active electrodes at activation

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

Cortical auditory responses according to hearing rehabilitation in unilateral hearing loss. [2020]

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

General Health Quality of Life Instruments Underestimate the Impact of Bilateral Cochlear Implantation. [2020]

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

Long-term asymmetric hearing affects cochlear implantation outcomes differently in adults with pre- and postlingual hearing loss. [2018]

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

"Aural Patching" After Bilateral Cochlear Implantation Is Challenging for Children With Prior Long-Term Unilateral Implant Experience. [2021]

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

Cochlear implants in young children. [2019]

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. Korea (South) pubmed.ncbi.nlm.nih.gov

Long-term evolution of the electrical stimulation levels for cochlear implant patients. [2021]

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

Development of an Optimized Protocol for Cochlear Implant Care to Increase Cochlear Implant Access. [2023]

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

Prospective randomized clinical trial of advanced cochlear implants: preliminary results of a Department of Veterans Affairs Cooperative Study. [2017]

10. Spain pubmed.ncbi.nlm.nih.gov

Recognition of music and melody in patients with cochlear implants, using a new programming approach for frequency assignment. [2019]

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

Participant-generated Cochlear Implant Programs: Speech Recognition, Sound Quality, and Satisfaction. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Do the minimum and maximum comfortable stimulation levels influence the cortical potential latencies or the speech recognition in adult cochlear implant users? [2022]

13. England pubmed.ncbi.nlm.nih.gov

Bilateral input protects the cortex from unilaterally-driven reorganization in children who are deaf. [2013]