Early Cochlear Implant Use

ConditionCochlear Implant Users

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-85

SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Diagnosed cognitive or communicative disorders (other than deafness)

Below 18 years of age

Above the age of 85 years old.

Trial population

The population includes hearing impaired adults. Both genders will be recruited. All subjects will be recruited from the NYU Cochlear Implant Clinic.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Take home tests
Other intervention
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.

Treatment groups

25 Participants

are divided into 2 treatment groups

Group A: Newly Implanted Users1 intervention

Group B: Experienced Cochlear Implant Users1 intervention

Trial outcomes

Primary outcomes

Change in percentage of correct responses during speech perception tests

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%.

Time frame

Baseline, 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Source ClinicalTrials.gov

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