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.

Study Overview

• Status: Recruiting
• Conditions: Hearing Impairment
• Intervention / Treatment: Device: SEDA

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalia Stupak; Phone Number: 646-501-4153; Email: natalia.stupak@nyulangone.org
• Study Contact Backup: Name: David M. Landsberger; Phone Number: 212-263-8455; Email: David.landsberger@nyulangone.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • Tisch Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cochlear Implant Users; Participants will complete up to 4 experiments evaluating the use of the Speech Enhancement using Dynamic thresholding Approach (SEDA) algorithm. Each testing session will take between 4-6 hours to complete. Testing sessions will continue until the completion of the experiments.	Device: SEDA; Speech Enhancement using Dynamic thresholding Approach (SEDA) is a software algorithm that removes background noise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Words Correctly Recognized in Noisy Conditions with SEDA NR	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.	Up to Year 2 (Completion of Experiment 1.1)
Percent of Words Correctly Recognized in Noisy Conditions without NR	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.	Up to Year 2 (Completion of Experiment 1.1)
Percent of Words Correctly Recognized in Quiet Conditions with SEDA NR	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.	Up to Year 2 (Completion of Experiment 1.1)
Percent of Words Correctly Recognized in Quiet Conditions without NR	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.	Up to Year 2 (Completion of Experiment 1.1)
Visual Analogue Scale (VAS) Rating of SEDA NR	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.	Up to Year 2 (Completion of Experiment 1.2)
Percent of Words Correctly Recognized in Noisy Conditions with Clinical NR	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.	Up to Year 2 (Completion of Experiment 2)
Percent of Words Correctly Recognized in Quiet Conditions with Clinical NR	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.	Up to Year 2 (Completion of Experiment 2)
Percent of Words Correctly Recognized with no SEDA NR	Participants will listen to sentences and repeat all the words they heard. This outcome measures the percent of words correctly recognized without SEDA NR.	Up to Year 2 (Completion of Experiment 4)
Percent of Words Correctly Recognized with Standard SEDA NR	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.	Up to Year 2 (Completion of Experiment 4)
Percent of Words Correctly Recognized with Low-Computation SEDA NR	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	Up to Year 2 (Completion of Experiment 4)
Percent of Words Correctly Recognized with Very Low-Computation SEDA NR	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.	Up to Year 2 (Completion of Experiment 4)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: David M. Landsberger, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss
• Other Study ID Numbers: 22-00815; SB1DC018761 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: David.landsberger@nyulangone.com. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to David.landsberger@nyulangone.com. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No