Early Cochlear Implant Use

Recruiting

• Conditions: Cochlear Implant Users

• Registration Number: NCT07114744
• Lead Sponsor: NYU Langone Health

Brief Summary

This observational study will examine newly activated cochlear implant users and determine whether their abilities to discern simple sounds change and relate to improved speech perception. Take-home computers and test-equipment will be sent home, and subjects will complete approximately 25 test sessions over the first 3 months of cochlea implant use. Then, subjects will be tested 3 more times in the laboratory until 1 year-post activation. The primary objective is to determine and quantify how sounds change and speech perception improves over the course of early cochlear implant use.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-11
• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Primary Completion: 2027-05-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Postlingually deaf cochlear implant users
2. severe or profound hearing loss
3. who do not have other diagnoses communicative or cognitive disorders.
4. Test population: no prior experience with cochlear implants (recruitment happens prior to cochlear implantation).
5. Control population: subjects who have used the same stimulation strategy since initial stimulation, who note no continuing improvements or changes with their devices with respect to speech comprehension.

Exclusion Criteria

1. Diagnosed cognitive or communicative disorders (other than deafness)
2. Below 18 years of age
3. Above the age of 85 years old.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in percentage of correct responses during speech perception tests	Baseline, 1 year	Speech perception tests involves presentation of a speech stimulus (may be a word, sentence, nonsense words, or other speech sounds) and subjects will have to indicate what they heard. The total score is the percentage of speech stimulus correctly understood, ranging from 0-100%.

Trial Locations

Locations (1)

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