Cochlear Implant Programming for Hearing Loss

Recruiting at 2 trial locations

Overseen By Julie Arenberg

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts Eye and Ear Infirmary

Disqualifiers: Hearing loss, Informed consent, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand how cochlear implants, devices placed in the inner ear to assist with severe hearing loss, affect hearing in both children and adults. Researchers are testing new methods for programming these implants to enhance speech perception and speed of adaptation to new settings. Participants will be divided into groups to test different implant programming strategies. Individuals with a cochlear implant from specific manufacturers who speak American English might be suitable for this study. As an unphased trial, this study allows participants to contribute to innovative research that could improve 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 these cochlear implant programming methods are safe?

Studies have shown that cochlear implants, devices placed in the inner ear to aid hearing, are generally safe for people of all ages. Research indicates that these implants are the standard treatment for severe to profound hearing loss. Despite some medical and device-related risks, these implants are largely considered safe for patients.

The new sound processing method tested with these implants aims to improve speech understanding. This involves altering how the implant interacts with the hearing system. Although this specific method is new, cochlear implant technology has a strong safety record.

Overall, cochlear implants are a well-established and safe treatment for hearing loss, and the new adjustments being tested build on this reliable technology. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to improve cochlear implant programming for hearing loss. Unlike traditional cochlear implants, which rely on fixed processing strategies, this trial tests an experimental processing strategy that could better match the electrode-neuron interface. This approach aims to enhance sound quality and speech understanding by optimizing how the implant interacts with the auditory nerve. By potentially offering a more personalized listening experience, this method could significantly improve everyday hearing for cochlear implant users.

What evidence suggests that this trial's cochlear implant programming methods could be effective for hearing loss?

Research shows that cochlear implants, devices placed in the ear to assist those with severe hearing loss, perform better with careful programming and design. This trial will evaluate various sound processing strategies for cochlear implants. Studies have indicated that electrodes placed along the side of the cochlea, known as lateral wall electrodes, preserve hearing more effectively than other types. The position of these electrodes is crucial, as certain placements enhance the connection between the implant and the ear's nerve cells. Additionally, evidence suggests that early implantation, especially in children, leads to better hearing outcomes. These findings guide the development of new sound processing methods to improve hearing for cochlear implant users. Participants in this trial will experience different processing strategies, including an experimental sound processing strategy and a sham comparator, to assess their effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Julie Arenberg

Principal Investigator

Massachusetts Eye and Ear

Are You a Good Fit for This Trial?

This trial is for children and adults with severe hearing loss who have cochlear implants from specific manufacturers. Adults must be at least 18, native English speakers, while children can participate from 6 months old. Participants cannot join if they're unable to consent or meet certain protocol criteria like age of hearing loss onset.

Inclusion Criteria

I have a cochlear implant and fit the specific age criteria for hearing loss or implantation.

My child is over 6 months old, speaks American English, and has a cochlear implant from Advanced Bionics, Cochlear, or MED-EL.

I am 18 or older, speak American English, and wear a cochlear implant from Advanced Bionics, Cochlear, or MED-EL.

Exclusion Criteria

Exclusion for all Cochlear Implant Subjects: Inability to provide informed consent, does not meet the inclusion criteria for a specific study protocol, such as age of onset of hearing loss, age of cochlear implantation, duration of deafness, number of active electrodes in the cochlear implant device, unable to carry out the study protocol or tasks required in the study

Exclusion for all Normal Hearing Subjects: Inability to provide informed consent, hearing loss, or significant history of hearing related issues, unable to carry out the study protocol or tasks required in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive experimental cochlear implant programming and are assessed weekly for 10 weeks

10 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cochlear Implant Electrode-neuron Interfaces

Trial Overview

The study aims to understand how cochlear implants affect auditory development and test new programming methods for better speech perception in users. It involves cognitive assessments, threshold and psychophysical testing, speech tests, and telemetry recordings over time.

How Is the Trial Designed?

Group I: Performance Assessed with Experimental Sound Processing Strategy Experimental Treatment 1 Intervention

Patients listening to experimental cochlear implant processing strategy.

Group II: Control Active Control 1 Intervention

Patients listening to their clinical cochlear implant using their "own" processor (their everyday listening situation).

Group III: Experimental Control Placebo Group 1 Intervention

Patients listening to experimental cochlear implant using a processing strategy like thier clinical program, a "clinical like" program.

Cochlear Implant Electrode-neuron Interfaces is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cochlear Implant for:

• Severe to profound sensorineural hearing loss

Approved in United States as Cochlear Implant for:

• Severe to profound sensorineural hearing loss
• Single-sided deafness

Approved in Canada as Cochlear Implant for:

• Severe to profound sensorineural hearing loss

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

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]

The Utah Electrode Array, a new type of penetrating microelectrode, can be implanted directly into the cochlear nerve, producing stable brainstem responses with a median stimulation threshold of just 15 microA, indicating its potential for effective auditory stimulation.

This innovative electrode technology could significantly reduce the current required for stimulation and minimize issues like cross-talk, making it a promising advancement for future cochlear implants that aim to provide clearer sound representation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear nerve stimulation with a 3-dimensional penetrating electrode array. Hillman, T., Badi, AN., Normann, RA., et al.[2019]

In a study of 58 adults, those with the precurved CI532 electrode array showed significantly better outcomes in hearing tests, including CNC word recognition and low frequency pure-tone averages, compared to those with the straight CI422/522 arrays.

The CI532 group also had lower impedances and pulse durations during programming, indicating potentially more efficient functioning, while overall charge levels remained similar between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matched Cohort Comparison Indicates Superiority of Precurved Electrode Arrays. Holder, JT., Yawn, RJ., Nassiri, AM., et al.[2020]

The study on guinea pigs with chronic intracochlear electrodes revealed that different electrode configurations (monopolar vs. bipolar) significantly affect the strength-duration relationship of electrically evoked auditory responses, with monopolar stimulation yielding steeper response functions.

The findings suggest that central mechanisms of stimulus integration play a role in auditory processing beyond the auditory nerve, which could inform the design of more effective auditory prosthetic devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional responses from guinea pigs with cochlear implants. I. Electrophysiological and psychophysical measures. Miller, CA., Woodruff, KE., Pfingst, BE.[2019]

Cochlear implants have evolved significantly over the past decade, leading to a variety of options that can complicate the selection process for patients and clinicians.

Key characteristics of cochlear implants include the number of channels and electrodes, encoding strategies, signal transmission methods, stimulation sites, and current diffusion types, all of which influence their effectiveness and application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[General principles of conception of cochlear implants]. Deguine, O., Fraysse, B., Corvera, G., et al.[2006]

Cochlear implants are highly effective, with over 60,000 users worldwide, largely due to advanced electrode arrays that ensure close contact with auditory neurons and long-term reliability in the inner ear.

Despite advancements in integrated circuit techniques, current cochlear electrode arrays are still manually constructed using wire-based technologies, though efforts are underway to automate their production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear electrode arrays: past, present and future. Spelman, FA.[2007]

Cochlear implants have evolved significantly from single-channel to multi-channel arrays, improving their ability to stimulate the auditory nerve directly, but they still do not provide the same experience as normal hearing.

Future advancements in hearing implants may rely on innovative technologies like regenerative techniques and optogenetics, which could lead to devices that restore more natural hearing capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioengineering applications for hearing restoration: emerging biologically inspired and biointegrated designs. Brant, JA., Adewole, DO., Vitale, F., 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]

The active transcutaneous bone conduction implant (BCI602) significantly improved hearing outcomes in 30 adult patients with single-sided deafness, showing a mean aided pure-tone threshold of 34.2 dB HL and enhanced speech discrimination and sound localization abilities.

Patients reported substantial subjective benefits, with significant improvements in communication ease and reduced tinnitus, indicating that the BCI602 device is both effective and safe for individuals with acquired single-sided deafness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness: A Prospective Multicenter Study. Kim, H., Park, MK., Park, SN., et al.[2023]

A new system for cochlear implant insertion and training in rats has been developed, allowing researchers to study how the central auditory system adapts to cochlear implant signals, which is crucial for improving future neuroprosthetics.

The study demonstrated that rats fitted with cochlear implants could learn to perform auditory tasks, indicating that the system effectively mimics human implantation and provides insights into the neural mechanisms involved in auditory processing and plasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A physiological and behavioral system for hearing restoration with cochlear implants. King, J., Shehu, I., Roland, JT., et al.[2019]

Cochlear implants are an effective treatment for individuals with severe to profound hearing loss, but their success heavily relies on quality programming of the device.

The review discusses various programming techniques, including those tailored for children and objective methods, highlighting the importance of these techniques in optimizing the performance of cochlear implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear implant programming. Shapiro, WH., Bradham, TS.[2011]

The Utah Electrode Array neuroprosthesis demonstrated significantly lower stimulation thresholds (one to two orders of magnitude) compared to conventional cochlear implants, suggesting improved efficacy in cochlear nerve stimulation.

In a study involving 12 cats, the neuroprosthesis showed stable auditory responses for up to 52 hours without causing significant nerve damage, indicating its potential safety and effectiveness as a new treatment for profound deafness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a novel eighth-nerve intraneural auditory neuroprosthesis. Badi, AN., Kertesz, TR., Gurgel, RK., et al.[2016]

The Cochlear Corporation's multi-electrode intracochlear implant is made from biocompatible materials and allows for atraumatic insertion, minimizing trauma during the procedure, especially when proper techniques are used.

Long-term use of the implant, with stimulation lasting up to 8 years, has shown no adverse effects on spiral ganglion cells or electrode corrosion, indicating its safety and efficacy for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The biologic safety of the Cochlear Corporation multiple-electrode intracochlear implant. Webb, RL., Clark, GM., Shepherd, RK., et al.[2006]

Chronic electrical stimulation of the auditory nerve can lead to significant complications, including surgical trauma and electrode displacement, which may occur at various times after insertion.

Histopathological analysis revealed severe damage, such as loss of hair cells and spiral ganglion cells, as well as new bone growth, highlighting the need for improved design and safety measures in cochlear prostheses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cochlear pathology following chronic electrical stimulation in cats]. Ni, DF.[2007]

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