Sound Coding Strategies for Hearing Loss

Overseen By David M Landsberger, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Children implanted post-lingually

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

Compensation: Varies

Number of Visits: 1

Duration: 10 weeks

190 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well people hear with cochlear implants, aiming to improve sound perception for users. Researchers compare information from individuals with cochlear implants to those with normal hearing to better understand the auditory system. The trial includes various groups: adults who received implants after learning to speak, adults who received them early, and children with implants. Suitable participants include individuals with a cochlear implant, either placed before age 2 or after learning to speak, or those with normal hearing. As an unphased trial, participants contribute valuable insights that may 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 cochlear implants and sound coding strategies are safe for hearing loss?

Research has shown that cochlear implants are generally safe for both adults and children, significantly improving hearing for those with severe hearing loss. For example, one study found that young children handled the implants well. Long-term users also reported better hearing over time.

The FDA has approved cochlear implants for certain types of hearing loss, indicating their safety for most people. While all medical devices carry some risks, extensive research and FDA approval suggest that most users tolerate cochlear implants well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sound Coding Strategies for Hearing Loss trial because it explores innovative ways to enhance cochlear implant technology. Unlike traditional hearing aids that simply amplify sound, cochlear implants work by directly stimulating the auditory nerve. This trial aims to refine how sound is processed and delivered through these implants, potentially offering clearer, more natural hearing for individuals with severe hearing loss. The focus on different sound coding strategies could lead to significant improvements in speech recognition and overall auditory experience, especially for those who receive cochlear implants at different stages of life.

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

Research has shown that cochlear implants, one of the treatments under study in this trial, work well for people with moderate to severe hearing loss. Studies have found that these devices often improve hearing and are safe and reliable. A review of several studies found that cochlear implants are now the standard treatment for significant hearing loss. This trial will also explore new methods using artificial intelligence (AI) to enhance the performance of these devices. These AI methods aim to improve speech understanding and tailor sound experiences to the individual. Early research suggests these AI methods could make cochlear implants even more effective by improving sound processing. ^{6 7 8 9 10}

Who Is on the Research Team?

David M Landsberger, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for children and adults with cochlear implants implanted before age 2, those who have some hearing left with aids, or normal hearing. It's open to ages 7-35 if pre-lingually implanted and 18+ for post-lingual implantation or normal hearing. Post-lingually implanted children cannot participate.

Inclusion Criteria

I am 7 or older and got a cochlear implant before age 2, or I can hear with aids or normally.

I am 18 or older with either a cochlear implant received after learning to speak or normal hearing.

I am between 18 and 35 years old and received my implant before I could speak.

Exclusion Criteria

Children who got a cochlear implant after they learned to speak.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of participants' auditory performance and psychophysical abilities

1 day

1 visit (in-person)

Treatment

Participants undergo manipulations in cochlear implant coding strategies to improve psychophysical and speech recognition outcomes

10 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for changes in auditory performance and psychophysical abilities after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cochlear Implant
• Electric-only Spectral Resolution
• Modulation Detection Threshold (MDT) and Gap Detection Tasks
• Single-Electrode Pulse Train
• Sound Coding Strategy

Trial Overview The study tests how different sound coding strategies in cochlear implants affect auditory performance. Participants will try electric-only spectral resolution methods and single-electrode pulse trains to see which improves sound perception.

How Is the Trial Designed?

Group I: Late Adult Cochlear Implant (LateAdultCI) Experimental Treatment 3 Interventions

Post-lingually implanted adults, 18+ years

Group II: Early Child Cochlear Implant (EarlyChildCI) Experimental Treatment 3 Interventions

Early implanted children, ages 7-17 years

Group III: Early Adult Cochlear Implant (EarlyAdultCI) Experimental Treatment 2 Interventions

Early implanted adults, ages 18 to 35 years

Group IV: Cochlear Implant (CI) Experimental Treatment 1 Intervention

CI children, ages 7-17 years, with aided residual hearing (bimodal/contralateral, electric+acoustic/ipsilateral)

Group V: Normal Hearing Adults (NHA) Active Control 1 Intervention

18+ years, Control Group

Group VI: Normal Hearing Children (NHC) Active Control 1 Intervention

Ages 7-17 years, Control Group

Cochlear Implant is already approved in United States, European Union for the following indications:

Approved in United States as Cochlear Implant for:

• Single-sided deafness (SSD) in children aged 5 years and older
• Severe to profound sensorineural hearing loss in both ears

Approved in European Union as Cochlear Implant for:

• Severe to profound sensorineural hearing loss in both ears
• Single-sided deafness (SSD) in children and adults

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Cochlear implants and auditory brainstem implants provide patients with profound hearing loss the ability to perceive sound through electrical stimulation of the auditory pathway, which is crucial for communication.

Cochlear implants are effective for those with inner ear disorders and a functioning hearing nerve, while auditory brainstem implants are designed for patients with hearing nerve defects, highlighting the importance of thorough preoperative evaluations to determine the appropriate device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear implants and electrical brainstem stimulation in sensorineural hearing loss. Laszig, R., Aschendorff, A.[2019]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10816985/

Systematic Review of Auditory Training Outcomes in Adult ... Cochlear implantation has become the standard of care for rehabilitation of moderate to profound sensorineural hearing loss, with studies ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7851969/

Cochlear Implantation: Diagnosis, Indications, and Auditory ... Cochlear implantation, performed in specialized centers, is a safe and reliable technique and regularly enables the successful rehabilitation of hearing in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06086041

Predictive Study on Hearing Rehabilitation After Cochlear ... At present, it is very difficult to predict the outcome of cochlear implants in deaf patients with a cochlear implant indication prior to ...

4. nature.com nature.com/articles/s43856-024-00719-0

Rehabilitation of human hearing with a totally implantable ... Here, we present initial clinical results with the totally implantable cochlear implant (TICI). The primary objective of this study was to ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1672293024000187

Establishment of quantitative evaluation system for ... This study aims to develop an evaluation system for quantitatively evaluating the effectiveness of cochlear implants for hearing-impaired children.

6. 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: • ...

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

Safety and Early Outcomes of Cochlear Implantation ... This multi-center study examined the safety and effectiveness of cochlear implantation of children between 9 and 11 months of age.

8. mayoclinic.org mayoclinic.org/tests-procedures/cochlear-implants/about/pac-20385021

Cochlear implants This electronic device improves hearing in people who have severe hearing loss from inner ear damage.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1672293016300022

Safety and outcomes of cochlear implantation in the elderly In this study, auditory rehabilitation using traditional amplification (hearing aids) was associated with better DSST performance (Lin, 2011). While a complete ...

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

Long-Term Outcomes Following Cochlear Implantation The purpose of this study was to evaluate the clinical and audiological outcomes in long-term cochlear implant (CI) users, focusing on hearing performance and ...