Auditory Implant Evaluation for Hearing Loss
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: NYU Langone Health
Disqualifiers: Cognitive disorders, Neurological disorders, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
16789How 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.
1451011Eligibility 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.
Trial 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
Participant Groups
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.
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, United States for the following indications:
🇺🇸 Approved in United States as Utah Array for:
- Motor function restoration in paralyzed patients
- Clinical investigations of intracortical brain-machine interface technology
🇪🇺 Approved in European Union as Cochlear Implants for:
- Severe to profound sensorineural hearing loss
🇺🇸 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
Research Locations NearbySelect from list below to view details:
NYU Langone HealthNew York, NY
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor
Cochlear AmericasCollaborator
References
The multichannel auditory brainstem implant: how many electrodes make sense? [2004]Development of multichannel auditory brainstem implant (ABI) systems has been based in part on the assumption that audiological outcome can be optimized by increasing the number of available electrodes. In this paper the authors critically analyze this assumption on the basis of a retrospective clinical study performed using the Nucleus 22 ABI surface electrode array.
Ten-year follow-up of auditory brainstem implants: From intra-operative electrical auditory brainstem responses to perceptual results. [2023]The auditory brainstem implant (ABI) can provide hearing sensation to individuals where the auditory nerve is damaged. However, patient outcomes with the ABI are typically much poorer than those for cochlear implant recipients. A major limitation to ABI outcomes is the number of implanted electrodes that can produce auditory responses to electric stimulation. One of the greatest challenges in ABI surgery is the intraoperative positioning of the electrode paddle, which must fit snugly within the cochlear nucleus complex. While there presently is no optimal procedure for intraoperative electrode positioning, intraoperative assessments may provide useful information regarding viable electrodes that may be included in patients' clinical speech processors. Currently, there is limited knowledge regarding the relationship between intraoperative data and post-operative outcomes. Furthermore, the relationship between initial ABI stimulation with and long-term perceptual outcomes is unknown. In this retrospective study, we reviewed intraoperative electrophysiological data from 24 ABI patients (16 adults and 8 children) obtained with two stimulation approaches that differed in terms of neural recruitment. The interoperative electrophysiological recordings were used to estimate the number of viable electrodes and were compared to the number of activated electrodes at initial clinical fitting. Regardless of the stimulation approach, the intraoperative estimate of viable electrodes greatly overestimated the number of active electrodes in the clinical map. The number of active electrodes was associated with long-term perceptual outcomes. Among patients with 10-year follow-up, at least 11/21 active electrodes were needed to support good word detection and closed-set recognition and 14/21 electrodes to support good open-set word and sentence recognition. Perceptual outcomes were better for children than for adults, despite a lower number of active electrodes.
Pediatric Auditory Brainstem Implant Surgery: A New Option for Auditory Habilitation in Congenital Deafness? [2018]The auditory brainstem implant (ABI) is a neuroprosthetic device that provides sound sensations to individuals with profound hearing loss who are not candidates for a cochlear implant (CI) because of anatomic constraints. Herein we describe the ABI for family physicians.
Comparison of sound processing strategies for osseointegrated bone conduction implants in mixed hearing loss: multiple-channel nonlinear versus single-channel linear processing. [2015]Evaluation of a single-channel linear bone conduction implant sound processor (S-BCI) and a multiple-channel nonlinear bone conduction implant sound processor (M-BCI) with objective and subjective measures in patients with mixed hearing loss.
Auditory Brainstem Implant Array Position Varies Widely Among Adult and Pediatric Patients and Is Associated With Perception. [2018]The auditory brainstem implant (ABI) provides sound awareness to patients who are ineligible for cochlear implantation. Auditory performance varies widely among similar ABI cohorts. We hypothesize that differences in electrode array position contribute to this variance. Herein, we classify ABI array position based on postoperative imaging and investigate the relationship between position and perception.
[Use of the auditory brainstem neuroprosthesis in the Czech Republic]. [2006]Auditory brainstem implant (ABI) is an electroprosthetic device enabling sound sensations in deaf persons with a bilateral lesion of auditory nerves. Stimulation of auditory nuclei in the floor of the IVth ventricle is realized by an electrode array introduced during surgery in the lateral recess of the IVth ventricle.
'Compassionate use' protocol for auditory brainstem implantation in neurofibromatosis type 2: Early House Ear Institute experience. [2019]To report the preliminary outcomes of auditory brainstem implantation (ABI) under a compassionate use protocol for two ABI devices that are not approved by the US Food and Drug Administration.
Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness: A Prospective Multicenter Study. [2023]To investigate the safety and efficacy of a novel active transcutaneous bone conduction implant (BCI) device for patients with single-sided deafness (SSD).
Auditory brainstem implant in postmeningitis totally ossified cochleae. [2018]An auditory brainstem implant (ABI) is an option for auditory rehabilitation in patients with totally ossified cochleae who cannot receive a conventional cochlear implant.
Conformal in-ear bioelectronics for visual and auditory brain-computer interfaces. [2023]Brain-computer interfaces (BCIs) have attracted considerable attention in motor and language rehabilitation. Most devices use cap-based non-invasive, headband-based commercial products or microneedle-based invasive approaches, which are constrained for inconvenience, limited applications, inflammation risks and even irreversible damage to soft tissues. Here, we propose in-ear visual and auditory BCIs based on in-ear bioelectronics, named as SpiralE, which can adaptively expand and spiral along the auditory meatus under electrothermal actuation to ensure conformal contact. Participants achieve offline accuracies of 95% in 9-target steady state visual evoked potential (SSVEP) BCI classification and type target phrases successfully in a calibration-free 40-target online SSVEP speller experiment. Interestingly, in-ear SSVEPs exhibit significant 2nd harmonic tendencies, indicating that in-ear sensing may be complementary for studying harmonic spatial distributions in SSVEP studies. Moreover, natural speech auditory classification accuracy can reach 84% in cocktail party experiments. The SpiralE provides innovative concepts for designing 3D flexible bioelectronics and assists the development of biomedical engineering and neural monitoring.
Bilateral cochlear implants controlled by a single speech processor. [2010]This study aimed to assess, in one profoundly hearing impaired subject, potential benefits and limitations in placing bilaterally implanted scala tympani electrode arrays under control of a single speech processor.