Cochlear Implants for Hearing Loss

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, College Park

Disqualifiers: Neurological disorder, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

300 Participants Needed

Trial Summary

What is the purpose of this trial?

Cochlear implants (CIs) are devices that partially restore hearing for people with severe to profound hearing loss. This research focuses on CI users who use bilaterally implanted devices (two CIs, one on each side) and also "single-sided deafness" (SSD) CI users who use one CI together with good acoustic hearing in their opposite ear. The goal is to measure and understand the impact of large input asymmetries across the two ears. These asymmetries are common in BI-CI listeners and always present in SSD-CI users. Although most CI listeners benefit from a second source of auditory input, this project measures how these asymmetries limit speech understanding and spatial hearing. The long-term goal is countering or compensating for input asymmetries. Electrophysiological measures are used to describe the health of the auditory system. Behavioral measures are used to assess if training improves performance. CT imaging is utilized to describe the placement of the CIs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Targeted Aural Rehabilitation for hearing loss?

Research shows that cochlear implants significantly improve speech understanding and quality of life for adults with severe hearing loss. Additionally, computer-assisted home training for cochlear implant users has been shown to enhance phoneme recognition, suggesting that targeted rehabilitation can be effective. ^{1 2 3 4 5}

Is it safe to use cochlear implants for hearing loss?

Cochlear implants have been studied for safety, with some research focusing on complications and adverse events. Studies have used databases like the MAUDE to analyze complications, and trends in adverse events have been reviewed over time. While there are some risks, these studies help understand and improve the safety of cochlear implants. ^{6 7 8 9 10}

How is the treatment Targeted Aural Rehabilitation unique for cochlear implant patients?

Targeted Aural Rehabilitation is unique because it often involves computer-assisted speech training, allowing patients to practice at home with auditory and visual feedback, which can improve speech recognition and make the rehabilitation process more accessible and engaging compared to traditional methods. ^{11 12 13 14 15}

Research Team

Matthew J. Goupell, PhD

Principal Investigator

University of Maryland, College Park

Joshua G. Bernstein, PhD

Principal Investigator

Walter Reed National Military Medical Center; University of Maryland, College Park

Eligibility Criteria

This trial is for individuals with severe to profound hearing loss who are using cochlear implants (CIs). It's specifically aimed at those with bilateral CIs (one on each ear) or single-sided deafness (SSD), where one CI is used alongside normal hearing in the other ear. Participants should be able to undergo diagnostic tests, CT imaging, and targeted aural rehabilitation.

Inclusion Criteria

My hearing is normal, near-normal, or I have mild to moderate hearing loss.

Bilateral Cochlear Implant Users Arm: sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text

Bilateral Cochlear Implant Users Arm: two cochlear implants

Exclusion Criteria

Bilateral Cochlear Implant Users Arm: people with less than six months of device use will be excluded

Bilateral Cochlear Implant Users Arm: people who do not use oral language will be excluded

Unilateral Cochlear Implant User with Single-Sided Deafness Arm: people who do not use oral language will be excluded

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use cochlear implants to measure and understand the impact of input asymmetries across the ears

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including electrophysiological and behavioral measures

4 weeks

Treatment Details

Interventions

• Targeted Aural Rehabilitation

Trial Overview The study measures how differences in auditory input between two ears affect speech understanding and spatial hearing in CI users. It involves diagnostic tests of CI function, electrophysiological measures of auditory health, CT imaging for CI placement assessment, and aural rehabilitation to see if training can improve performance.

Participant Groups

Group I: Unilateral Cochlear Implant Users with Single-Sided Deafness Experimental Treatment 2 Interventions

Group II: Non-Implanted Listeners with Acoustic Hearing Experimental Treatment 1 Intervention

Group III: Bilateral Cochlear Implant Users Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

University of Maryland, College Park

Lead Sponsor

Trials

163

Recruited

46,800+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

Walter Reed National Military Medical Center

Collaborator

Trials

149

Recruited

33,800+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Findings from Research

Cochlear implantation significantly improves speech recognition and patient-reported outcomes in adults with severe-to-profound hearing loss, with average Dantale I scores increasing from 26% to 70% in quiet conditions and from 12% to 42% in noisy conditions after implantation.

The study, involving 39 Danish adult patients assessed before and at two points after implantation, shows that while significant improvements were noted at 4 months, further marginal gains were observed at 14 months, suggesting patients approach a performance plateau over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear Implantation Improves Both Speech Perception and Patient-Reported Outcomes: A Prospective Follow-Up Study of Treatment Benefits among Adult Cochlear Implant Recipients. Rasmussen, KMB., West, NC., Bille, M., et al.[2022]

In a study of 17 children with limited low-frequency hearing who underwent cochlear implantation (CI), electroacoustic stimulation (EAS) rehabilitation showed potential benefits, particularly in noisy environments, enhancing speech perception compared to CI-only mode.

Successful EAS rehabilitation was achieved in 9 out of 21 ears, with the postoperative low-frequency pure-tone average identified as a key predictive factor for better outcomes, suggesting that preserving low-frequency hearing during CI can improve auditory rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and Predictive Factors of Electroacoustic Stimulation Rehabilitation in Children With Limited Low-Frequency Hearing. Nam, GS., Song, MH., Choi, JY., et al.[2020]

Cochlear implants significantly improve hearing in profoundly hearing-impaired patients, with performance in a study of 63 patients showing a wide range of outcomes, including up to 62% correct word recognition and 98% enhancement in lipreading.

Prelingually deaf children benefit from cochlear implants but take longer to show improvements compared to postlingually deaf individuals, highlighting the need for tailored rehabilitation approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What can we learn about hearing aids from cochlear implants? Tyler, RS.[2019]

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]

In a study of 113 patients with Advanced Bionics Ultra cochlear implants, 17.7% experienced device failure, primarily in children, highlighting the need for ongoing monitoring of at-risk devices.

After revision surgeries, patients generally maintained stable auditory performance, indicating that revision procedures are effective and safe, with most patients opting to stay with the same manufacturer for their new devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HiRes ultra series cochlear implant field recall: failure rates and early outcomes. Winchester, A., Kay-Rivest, E., Friedmann, DR., et al.[2023]

A review of 31,857 adverse events from cochlear implants revealed that implants from manufacturer C had a higher incidence of complications, including infection (0.97%), cerebrospinal fluid leak (0.07%), extrusion (0.44%), and facial nerve stimulation (0.11%).

Manufacturer B's implants were linked to a higher rate of meningitis (0.07%), highlighting the importance of considering both patient risk factors and the specific manufacturer when evaluating the safety of cochlear implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of cochlear implants: a MAUDE database study. Jinka, S., Wase, S., Jeyakumar, A.[2023]

The study involved 15 patients with severe-to-profound mixed hearing loss and demonstrated that the Codacs direct acoustic cochlear implant significantly improved sound field thresholds by an average of 48 dB after 3 months of activation.

Patients also showed substantial improvements in word recognition scores, with increases of up to 78.2%, and a 27% reduction in hearing difficulty, indicating the device's efficacy in enhancing hearing capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter study with a direct acoustic cochlear implant. Lenarz, T., Zwartenkot, JW., Stieger, C., et al.[2022]

Recent advancements in aural rehabilitation have led to the development of computerized programs that provide consistent, cost-effective, and convenient training for hearing aid users and cochlear implant recipients, enhancing traditional techniques like speech tracking and auditory training.

Research is also exploring the use of pharmaceuticals, such as d-amphetamine, to improve outcomes in intensive aural rehabilitation for cochlear implant patients, indicating a potential new avenue for enhancing rehabilitation effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technologic advances in aural rehabilitation: applications and innovative methods of service delivery. Sweetow, RW., Sabes, JH.[2018]

Group interventions for adult cochlear implant users, such as Auditory Training Groups and Thematic Group Workshops, are well accepted and rated positively by participants, indicating their effectiveness in rehabilitation.

Participants highlighted the importance of training in speech perception in noise and communicative exchange, suggesting that these group settings can enhance both auditory skills and social interaction among CI users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Auditory group therapy in adult cochlear implant rehabilitation]. Glaubitz, C., Lehmann, EK., Weber, L., et al.[2020]

Cochlear implant patients often require additional auditory rehabilitation beyond the implantation itself to fully benefit from the device, as learning to interpret electrically stimulated speech can be challenging.

A new computer-assisted speech-training program has been shown to effectively improve speech recognition in cochlear implant patients by providing targeted training, auditory and visual feedback, and maintaining patient engagement, making rehabilitation more accessible and motivating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Assisted Speech Training for Cochlear Implant Patients: Feasibility, Outcomes, and Future Directions. Fu, QJ., Galvin, JJ.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Cochlear Implantation Improves Both Speech Perception and Patient-Reported Outcomes: A Prospective Follow-Up Study of Treatment Benefits among Adult Cochlear Implant Recipients. [2022]

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

Outcomes and Predictive Factors of Electroacoustic Stimulation Rehabilitation in Children With Limited Low-Frequency Hearing. [2020]

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

Preliminary evaluation of computer-assisted home training for French cochlear implant recipients. [2023]

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

What can we learn about hearing aids from cochlear implants? [2019]

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

Cochlear Implant Therapy Improves the Quality of Life in Older Patients-A Prospective Evaluation Study. [2023]

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

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

7. Ireland pubmed.ncbi.nlm.nih.gov

Adverse events in pediatric cochlear implant patients undergoing magnetic resonance imaging. [2021]

8. England pubmed.ncbi.nlm.nih.gov

HiRes ultra series cochlear implant field recall: failure rates and early outcomes. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Complications of cochlear implants: a MAUDE database study. [2023]

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

Multicenter study with a direct acoustic cochlear implant. [2022]

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

Technologic advances in aural rehabilitation: applications and innovative methods of service delivery. [2018]

12. Germany pubmed.ncbi.nlm.nih.gov

[Auditory group therapy in adult cochlear implant rehabilitation]. [2020]

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

Maximizing Cochlear Implant Outcomes with Short-Term Aural Rehabilitation. [2022]

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

Computer-Assisted Speech Training for Cochlear Implant Patients: Feasibility, Outcomes, and Future Directions. [2021]

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

Results following cochlear implantation and rehabilitation. [2019]