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NCT Number: NCT05805384

Evaluating a Noise Reduction Algorithm With Cochlear Implant Users

In this study, a noise reduction algorithm will be implemented in various listening situations to evaluate its effectiveness in improving speech understanding for cochlear implant users ages 12 and older.

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Key information

Conditions

Hearing Impairment Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tisch Hospital

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

  • At least 12 years of age.
  • Be post-lingually deafened cochlear implant recipients with at least 6 months experience regardless of manufacturer.
  • The PI must also deem the child to be developmentally able to complete the experiments.

Exclusion criteria

  • Anyone who is not a cochlear implant user or is aged under 12 years.

Treatment and study plan

SEDA

Device

Speech Enhancement using Dynamic thresholding Approach (SEDA) is a software algorithm that removes background noise.

Primary outcomes

  1. Percent of Words Correctly Recognized in Noisy Conditions with SEDA NR

    Time frame: Up to Year 2 (Completion of Experiment 1.1)

    Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized in noisy listening conditions while using the SEDA Noise Reduction (NR) algorithm.

  2. Percent of Words Correctly Recognized in Noisy Conditions without NR

    Time frame: Up to Year 2 (Completion of Experiment 1.1)

    Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized in noisy listening conditions without SEDA NR.

  3. Percent of Words Correctly Recognized in Quiet Conditions with SEDA NR

    Time frame: Up to Year 2 (Completion of Experiment 1.1)

    Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized in quiet listening conditions while using the SEDA NR.

  4. Percent of Words Correctly Recognized in Quiet Conditions without NR

    Time frame: Up to Year 2 (Completion of Experiment 1.1)

    Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized in quiet listening conditions with SEDA NR.

  5. Visual Analogue Scale (VAS) Rating of SEDA NR

    Time frame: Up to Year 2 (Completion of Experiment 1.2)

    Participants will be presented with two buttons: one button will play a sample with SEDA NR and the other will play a sample without SEDA NR. Listeners will report which sample was preferable by clicking on a horizontal visual analog scale (VAS). VAS ratings will be scored on a scale of -10 to 10 where positive numbers indicate a preference for SEDA NR and negative numbers indicate a preference for not using SEDA NR. The magnitude of the absolute value of the score indicates the strength of the preference.

  6. Percent of Words Correctly Recognized in Noisy Conditions with Clinical NR

    Time frame: Up to Year 2 (Completion of Experiment 2)

    Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized in noisy listening conditions while using a clinical NR algorithm.

  7. Percent of Words Correctly Recognized in Quiet Conditions with Clinical NR

    Time frame: Up to Year 2 (Completion of Experiment 2)

    Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized in quite listening conditions while using a clinical NR algorithm.

  8. Percent of Words Correctly Recognized with no SEDA NR

    Time frame: Up to Year 2 (Completion of Experiment 4)

    Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized without SEDA NR.

  9. Percent of Words Correctly Recognized with Standard SEDA NR

    Time frame: Up to Year 2 (Completion of Experiment 4)

    Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized with Standard SEDA NR.

  10. Percent of Words Correctly Recognized with Low-Computation SEDA NR

    Time frame: Up to Year 2 (Completion of Experiment 4)

    Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized with the Low-Computation SEDA NR, which is designed to have minimal computation while maintaining an Extended Short-Time Objective Intelligibility Predictor (ESTOI) value similar to the "standard" SEDA implementation

  11. Percent of Words Correctly Recognized with Very Low-Computation SEDA NR

    Time frame: Up to Year 2 (Completion of Experiment 4)

    Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized with the Very Low-Computation SEDA NR, which is designed to have a reasonable ESTOI value with minimal computational requirements.

Study contacts

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

David M. Landsberger

CONTACT

[email protected]

212-263-8455

Natalia Stupak

CONTACT

[email protected]

646-501-4153

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
2023
Primary completion
2027
Study completion
2027
First posted
Apr 10, 2023
Registry last updated
Dec 17, 2025

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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