Auditory Implant Evaluation for Hearing Loss
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Measurement
Participants undergo perceptual and physiological measurements to evaluate auditory processing
Follow-up
Participants are monitored for any immediate effects or feedback after measurements
Treatment Details
Interventions
- Electrode-Neural Interface
Electrode-Neural Interface is already approved in United States, European Union for the following indications:
- Motor function restoration in paralyzed patients
- Clinical investigations of intracortical brain-machine interface technology
- Severe to profound sensorineural hearing loss
- 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
Cochlear Americas
Collaborator