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

Not Applicable

Recruiting

• Conditions: Deafness
• Interventions: Device: Electrode-Neural Interface

• Registration Number: NCT05810220
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-02
• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-04-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hearing-Impaired Individuals who use Cochlear Implants or Auditory Brainstem Implant (ABI) Devices	Electrode-Neural Interface	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.

Primary Outcome Measures

Name	Time	Method
Percent of Correctly-Identified Stimuli Characteristics when Two or More Stimuli are Presented	Day 1 (Visit 1 - Average visit length is about 3 hours)	Two or more stimuli will be presented to participants, who will indicate which one is louder, which is higher pitched, or which one is different. The outcome is the percent of stimuli characteristics that are correctly identified.
Percent of Correctly-Identified Speech Materials	Day 1 (Visit 1 - Average visit length is about 3 hours)	Participants will listen to speech sounds and indicate what sentence or word they heard. The outcome is the percent of speech sounds that are correctly identified.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States