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NCT Number: NCT07114744

Early Cochlear Implant Use

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.

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postlingually deaf cochlear implant users
  • severe or profound hearing loss
  • who do not have other diagnoses communicative or cognitive disorders.
  • Test population: no prior experience with cochlear implants (recruitment happens prior to cochlear implantation).
  • 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

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

Treatment and study plan

Take home tests

Other

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 outcomes

  1. Change in percentage of correct responses during speech perception tests

    Time frame: 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%.

Study contacts

Contact information is provided by the study sponsor or research team.

Ariel E. Hight, PhD

CONTACT

[email protected]

212-263-7217

Mario A. Svirsky, PhD

CONTACT

[email protected]

212-263-7217

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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