Recruiting

Cochlear Implant

Sponsor:

NYU Langone Health

Code:

NCT07114744

Conditions

Cochlear Implant Users

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Take home tests

Study Details

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.

Conditions

Cochlear Implant Users

Study ID

NCT07114744

Start date

Jun 11, 2025

Status verified date

Jun, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Newly Implanted Users

Participants have no prior experience with cochlear implants (recruitment happens prior to cochlear implantation) will complete at home testing (\~25 sessions) over \~3 months of implant use.

Experienced Cochlear Implant Users

Participants who have used the same stimulation strategy since initial stimulation will complete at home testing (\~25 sessions) over \~3 months of implant use.

Interventions

Take home tests

These tests will test the discriminability of sounds that vary systematically along the frequency and temporal dimensions of sound. Over the course of the 3 months post-activation, subjects will self-complete "take-home" tests at location of their choosing. Each test session will include the entire test-battery will be repeated frequency as often as every day and then reducing frequency of testing corresponding to the rate of speech perception improvement.

Primary outcome measure

  • Change in percentage of correct responses during speech perception tests [ Time Frame: Baseline, 1 year ]

Central Contacts and Locations

Central contacts

Ariel E. Hight, PhD

212-263-7217Ariel.hight@nyulangone.org

Mario A. Svirsky, PhD

212-263-7217Mario.svirsky@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-07-01.