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

Trial Summary

What is the purpose of this trial?

Despite the success of cochlear implants, devices surgically placed in the inner ears of patients with severe hearing loss, there remains substantial variability in the overall speech perception outcomes for the children and adults who receive them. The main goals of this project are: i) to improve our understanding of how cochlear implants affect the developing auditory system, ii) apply that knowledge to test new methods for programming children and adults, and iii) to study how long it takes listeners to adapt to new cochlear implant programs over the short- and long-term. The results will improve our understanding of how the deafened auditory system develops with cochlear implant stimulation and advance clinical practice to improve hearing outcomes in cochlear implant listeners.

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 Electrode-neuron Interfaces, Cochlear Implant, Bionic Ear, Auditory Implant for hearing loss?

Research shows that cochlear implants, which are devices that help provide hearing to deaf patients, can be effective, although results vary. Studies on animals and humans indicate that different electrode designs and configurations can improve hearing outcomes by better stimulating the auditory nerve and reducing interference between electrodes. ^{1 2 3 4 5}

Is the cochlear implant generally safe for humans?

Research shows that cochlear implants are generally safe for humans. The materials used are compatible with the body, and the device can be inserted and removed with minimal trauma. Long-term use has not shown harmful effects on hearing-related cells in patients. ^{6 7 8 9 10}

How is the Cochlear Implant Electrode-neuron Interfaces treatment different from other treatments for hearing loss?

Cochlear Implant Electrode-neuron Interfaces are unique because they bypass damaged parts of the ear and directly stimulate the auditory nerve using an array of electrodes, which is different from hearing aids that simply amplify sound. This treatment involves advanced technology like multi-channel arrays and precise electrode placement to improve hearing, especially for those with severe to profound hearing loss. ^{2 11 12 13 14}

Research Team

Julie Arenberg

Principal Investigator

Massachusetts Eye and Ear

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

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

Cochlear nerve stimulation with a 3-dimensional penetrating electrode array. [2019]

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

Development of a novel eighth-nerve intraneural auditory neuroprosthesis. [2016]

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

Matched Cohort Comparison Indicates Superiority of Precurved Electrode Arrays. [2020]

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

A physiological and behavioral system for hearing restoration with cochlear implants. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Functional responses from guinea pigs with cochlear implants. I. Electrophysiological and psychophysical measures. [2019]

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

The biologic safety of the Cochlear Corporation multiple-electrode intracochlear implant. [2006]

7. England pubmed.ncbi.nlm.nih.gov

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

8. 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]

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

Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness: A Prospective Multicenter Study. [2023]

10. China pubmed.ncbi.nlm.nih.gov

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

11. France pubmed.ncbi.nlm.nih.gov

[General principles of conception of cochlear implants]. [2006]

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

Cochlear implant programming. [2011]

13. Switzerland pubmed.ncbi.nlm.nih.gov

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

14. England pubmed.ncbi.nlm.nih.gov

Bioengineering applications for hearing restoration: emerging biologically inspired and biointegrated designs. [2022]