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

Trial Summary

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 data supports the effectiveness of the treatment Cochlear Implant, Bionic Ear, Auditory Prosthesis, Electric-only Spectral Resolution, Modulation Detection Threshold (MDT) and Gap Detection Tasks, Single-Electrode Pulse Train, Sound Coding Strategy?

Research shows that new sound coding strategies for cochlear implants, like the FOF1F2 and SCORE, improve speech understanding, especially in noisy environments and at low sound levels. These strategies help users recognize more words correctly and enhance speech intelligibility by better encoding sound loudness. ^{1 2 3 4 5}

Is the sound coding strategy for hearing loss generally safe for humans?

Research shows that cochlear implants, which are a type of sound coding strategy, are generally safe for humans. However, there can be nerve damage if the stimulation parameters (like intensity and duration) are not well controlled over time. ^{6 7 8 9 10}

How is the cochlear implant treatment unique for hearing loss?

Cochlear implants use advanced sound coding strategies, like the SCORE and eTone, to improve speech perception by enhancing pitch and loudness information, which is not possible with traditional hearing aids. These strategies help users better understand speech in noisy environments and improve music perception by accurately encoding sound frequencies. ^{1 2 5 11 12}

What is the purpose of this trial?

The purpose of this study is to understand performance with a cochlear implant. The long-term goals of this research are to improve sound perception with cochlear implants and to better understand the functioning of the auditory system. Information from individuals with and without cochlear implants will be compared.

Research Team

David M Landsberger, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Recent developments with the nucleus 22-electrode cochlear implant: a new two formant speech coding strategy and its performance in background noise. [2004]

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

Application of real-time loudness models can improve speech recognition for cochlear implant users. [2013]

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

Coding of Electrical Stimulation Patterns for Binaural Sound Coding Strategies for Cochlear Implants. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Cochlear implants and electrical brainstem stimulation in sensorineural hearing loss. [2019]

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

Speech coding strategies and revised cochlear implant candidacy: an analysis of post-implant performance. [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. Switzerland pubmed.ncbi.nlm.nih.gov

Some practical considerations in development of multichannel scala tympani prostheses. [2019]

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

Clinical outcomes with the Kanso™ off-the-ear cochlear implant sound processor. [2018]

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

Coding strategies for multichannel cochlear prostheses. [2007]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Speech processing in vocoder-centric cochlear implants. [2019]

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

Development of a temporal fundamental frequency coding strategy for cochlear implants. [2013]