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Early Cochlear Implant Use

NYU Langone Health logo

NYU Langone Health

Status

Enrolling

Conditions

Cochlear Implant Users

Treatments

Other: Take home tests

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT07114744
24-01603
K99DC021727 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

25 participants in 2 patient groups

Newly Implanted Users
Description:
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.
Treatment:
Other: Take home tests
Experienced Cochlear Implant Users
Description:
Participants who have used the same stimulation strategy since initial stimulation will complete at home testing (\~25 sessions) over \~3 months of implant use.
Treatment:
Other: Take home tests

Trial contacts and locations

1

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Central trial contact

Ariel E. Hight, PhD; Mario A. Svirsky, PhD

Data sourced from clinicaltrials.gov

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