200 Participants Needed

Auditory Implant Evaluation for Hearing Loss

MA
Overseen ByMahan Azadpour
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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 Electrode-Neural Interface, Brain-Computer Interface (BCI), Brain-Machine Interface (BMI), Neural Interface, Electrode Array, Neuroprosthetic Device for hearing loss?

Research on auditory brainstem implants (ABI), a type of neuroprosthetic device, shows that having more active electrodes can improve hearing outcomes, such as word and sentence recognition, especially in children. However, the number of electrodes that can be effectively used varies, and better electrode positioning during surgery may lead to better hearing perception.12345

Is the auditory brainstem implant generally safe for humans?

The auditory brainstem implant (ABI) has been used in various studies and clinical settings, including compassionate use protocols, suggesting it is generally considered safe for human use, although specific safety data is not detailed in the provided research articles.16789

How is the Electrode-Neural Interface treatment for hearing loss different from other treatments?

The Electrode-Neural Interface, also known as a Brain-Computer Interface (BCI), is unique because it directly connects to the brain to help process auditory information, unlike traditional hearing aids or cochlear implants that amplify sound or stimulate the cochlea. This approach can potentially offer more precise auditory perception by bypassing damaged parts of the ear and directly interfacing with neural pathways.1451011

What is the purpose of this trial?

This is a basic investigational research study conducted with hearing impaired adults and children who use cochlear implant or auditory brainstem implant (ABI) devices. The study will evaluate different aspects of hearing and auditory processing in the users of implantable auditory devices.

Research Team

MA

Mahan Azadpour

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for hearing-impaired adults and children over 2 years old who use cochlear or auditory brainstem implants. Participants must not have other cognitive or communicative disorders, severe neurological issues, and their implant's electrodes must be functional without causing discomfort.

Inclusion Criteria

Patients' implant device must have useable electrodes that do not result in uncomfortable or unpleasant non-auditory sensation.
I am hearing impaired and use an ABI or cochlear implant.
I have no cognitive disorders except for hearing impairment and can visit the lab.

Exclusion Criteria

You do not have functioning electrodes in your implants.
I have a severe neurological disorder.
You have trouble thinking clearly or communicating with others, except for hearing problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Measurement

Participants undergo perceptual and physiological measurements to evaluate auditory processing

1 day
1 visit (in-person, average length 3 hours)

Follow-up

Participants are monitored for any immediate effects or feedback after measurements

1-2 weeks

Treatment Details

Interventions

  • Electrode-Neural Interface
Trial Overview The study investigates how well people with cochlear or auditory brainstem implants process sounds. It involves behavioral and electrophysiological experiments conducted in a lab setting to evaluate the effectiveness of these devices in restoring hearing functions.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Hearing-Impaired Individuals who use Cochlear Implants or Auditory Brainstem Implant (ABI) DevicesExperimental Treatment1 Intervention
Two types of measurements will be obtained: 1. Perceptual: one or more sounds are presented and a behavioral response is collected (e.g., judgements of loudness, pitch or other differences between the sounds, or identifying the word or sentence that was said). 2. Physiological: noninvasive electrophysiological recordings of nervous system activity.

Electrode-Neural Interface is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Utah Array for:
  • Motor function restoration in paralyzed patients
  • Clinical investigations of intracortical brain-machine interface technology
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Cochlear Implants for:
  • Severe to profound sensorineural hearing loss
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Auditory Brainstem Implants for:
  • Severe to profound hearing loss, particularly in cases where cochlear implants are not suitable

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Cochlear Americas

Collaborator

Trials
1
Recruited
200+

Findings from Research

In a study of 61 patients with neurofibromatosis Type 2 who received an eight-electrode auditory brainstem implant (ABI), it was found that having at least three functional electrodes is necessary for satisfactory speech recognition, particularly in vowel and word recognition tests.
While increasing the number of electrodes beyond three can improve performance, no significant benefits were observed for patients with more than five active electrodes, suggesting that the limited frequency information provided by surface stimulation restricts the effectiveness of multichannel ABI systems.
The multichannel auditory brainstem implant: how many electrodes make sense?Kuchta, J., Otto, SR., Shannon, RV., et al.[2004]
In a study of 24 patients (16 adults and 8 children) with auditory brainstem implants (ABIs), it was found that the number of viable electrodes estimated during surgery often overestimated the actual number of active electrodes available for hearing after the procedure.
Long-term perceptual outcomes were significantly better in children compared to adults, with at least 11 active electrodes needed for good word detection and 14 for effective open-set recognition, highlighting the importance of electrode activation for successful hearing restoration.
Ten-year follow-up of auditory brainstem implants: From intra-operative electrical auditory brainstem responses to perceptual results.Veronese, S., Cambiaghi, M., Tommasi, N., et al.[2023]
The auditory brainstem implant (ABI) is a promising option for individuals, including children, with profound hearing loss who cannot receive cochlear implants due to anatomical issues, such as severe cochlear or cochlear nerve deformities.
While ABI outcomes for patients with neurofibromatosis type 2 (NF2) are modest compared to cochlear implants, recent studies indicate that some non-tumor adult and pediatric users can achieve speech perception, highlighting its potential efficacy.
Pediatric Auditory Brainstem Implant Surgery: A New Option for Auditory Habilitation in Congenital Deafness?Shah, PV., Kozin, ED., Kaplan, AB., et al.[2018]

References

The multichannel auditory brainstem implant: how many electrodes make sense? [2004]
Ten-year follow-up of auditory brainstem implants: From intra-operative electrical auditory brainstem responses to perceptual results. [2023]
Pediatric Auditory Brainstem Implant Surgery: A New Option for Auditory Habilitation in Congenital Deafness? [2018]
Comparison of sound processing strategies for osseointegrated bone conduction implants in mixed hearing loss: multiple-channel nonlinear versus single-channel linear processing. [2015]
Auditory Brainstem Implant Array Position Varies Widely Among Adult and Pediatric Patients and Is Associated With Perception. [2018]
6.Czech Republicpubmed.ncbi.nlm.nih.gov
[Use of the auditory brainstem neuroprosthesis in the Czech Republic]. [2006]
'Compassionate use' protocol for auditory brainstem implantation in neurofibromatosis type 2: Early House Ear Institute experience. [2019]
Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness: A Prospective Multicenter Study. [2023]
Auditory brainstem implant in postmeningitis totally ossified cochleae. [2018]
Conformal in-ear bioelectronics for visual and auditory brain-computer interfaces. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Bilateral cochlear implants controlled by a single speech processor. [2010]
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