Cochlear Implants for Hearing Loss

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how cochlear implants (CIs) affect hearing in individuals with severe hearing loss. It focuses on those with two implants and those with one implant and good hearing in the other ear. The goal is to understand how hearing differences between the two ears impact speech understanding and spatial awareness. Participants will undergo targeted aural rehabilitation, a specialized training program, to determine if training can improve these differences. Suitable candidates include those who have used their cochlear implants for at least six months and primarily rely on oral language for communication. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance cochlear implant outcomes for future patients.

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 prior data suggests that cochlear implants are safe for hearing loss?

In a previous study, researchers found cochlear implants (CIs) to be very safe. Over 20 years, more than 91% of the devices continued to function well, demonstrating reliability for long-term use. Among children with implants in both ears, about 26% experienced some side effects, though most were not serious.

For individuals with hearing loss in one ear (single-sided deafness or SSD), using a cochlear implant in that ear can enhance hearing, such as understanding speech and identifying sound direction. Although the FDA has not approved this use, studies have shown it to be effective and safe. People often report a better quality of life with few serious side effects.

Overall, these findings suggest that cochlear implants, whether used in one ear or both, are generally well-tolerated. They can provide significant hearing improvements with a manageable risk of minor side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Targeted Aural Rehabilitation for cochlear implant users because it offers a personalized approach to improving hearing outcomes. Unlike traditional rehabilitation methods, which can be more generalized, this technique focuses on tailoring auditory training exercises specifically to the user's hearing profile and needs. This customization aims to enhance the user's ability to understand speech and process sounds in everyday environments, potentially leading to greater improvements in quality of life. By refining the rehabilitation process, this approach could provide more effective support for both bilateral and unilateral cochlear implant users, particularly those with single-sided deafness.

What evidence suggests that this trial's treatments could be effective for hearing loss?

This trial will compare different groups of participants: those with bilateral cochlear implants, those with unilateral cochlear implants for single-sided deafness, and non-implanted listeners with acoustic hearing. Research has shown that cochlear implants in both ears greatly improve hearing for people with severe hearing loss. Studies find that these individuals understand speech better and enjoy a higher quality of life compared to those with only one implant. For people who are deaf in one ear, cochlear implants also offer significant benefits, aiding in understanding spoken words and determining the direction of sounds. Overall, cochlear implants are a promising way to enhance hearing and quality of life for those with hearing loss. ^{4 6 7 8 9}

Who Is on the Research Team?

Joshua G. Bernstein, PhD

Principal Investigator

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

Matthew J. Goupell, PhD

Principal Investigator

University of Maryland, College Park

Are You a Good Fit for This Trial?

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.

I am a native English speaker with bilateral cochlear implants.

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10144087/

Efficacy of Bilateral Cochlear Implantation in Pediatric and ... Results revealed significant improvements in speech perception, speech production, and reading achievement after cochlear implantation. In adult ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11818215/

Bilateral Simultaneous Cochlear Implants: How Early ... Conclusions: Early activation is feasible and associated with consistent CI usage, providing potential benefits in auditory rehabilitation.

3. tandfonline.com tandfonline.com/doi/full/10.1080/14670100.2025.2516932

The benefit of bilateral cochlear implants in adults with ... Bilateral CIs provide audiological benefit over unilateral CI, resulting in hearing-specific QoL improvements. Lack of changes in generic QoL ...

4. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2769939

Hearing and Quality-of-Life Outcomes After Cochlear ... Older adults in this study achieved clinically meaningful improvement in both speech perception and patient-reported quality-of-life metrics ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0165587625001582

Exploring the impact of auditory verbal therapy duration (0, ... This study aimed to evaluate the impact of Auditory Verbal Therapy (AVT) on spoken language and pragmatic skills five years after cochlear implantation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11185016/

Safety and Early Outcomes of Cochlear Implantation ... Results revealed 60 adverse events in 41 children and 227 ears implanted (26%) of which 14 major events occurred in 11 children; all were ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11932275/

Long-Term Outcomes Following Cochlear Implantation In the survival analysis, the overall device survival rates were more than 96% in 10 years and 91% in 20 years. These data imply that CIs remain ...

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

Summary of Safety and Effectiveness Data (SSED) For individuals with single sided deafness the following contraindication is also applicable: • Duration of profound sensorineural hearing loss ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06293482

Safety and Effectiveness of Cochlear Implantation in an ... This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet ...