Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants

NYU Langone Health

Status: Enrolling

Conditions: Deafness

Treatments: Device: Electrode-Neural Interface

Study type: Interventional

Funder types: Other

Identifiers

NCT05810220

18-00323

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 2 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hearing impaired adult and or child (above 2 years old) who uses ABIs or cochlear implants.
• No diagnosis of any other communicative or cognitive disorder other than hearing impairment. The individual must be able to visit the lab in order to participate in behavioral and electrophysiological experiments.
• Patients' implant device must have useable electrodes that do not result in uncomfortable or unpleasant non-auditory sensation.

Exclusion criteria

• Diagnosed cognitive or communicative disorders (other than hearing impairment)
• Severe neurological disorders
• No useable electrodes in their implants

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Hearing-Impaired Individuals who use Cochlear Implants or Auditory Brainstem Implant (ABI) Devices

Experimental group

Description:

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.

Treatment:

Device: Electrode-Neural Interface