Evaluating a Noise Reduction Algorithm With Cochlear Implant Users

NCT05805384 | Recruiting FDA Device

• 2 other identifiers: 22-00815SB1DC018761
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Impairment

Outcome Measures

Primary Outcomes (11)

• 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)

Study Arms (1)

Cochlear Implant Users

EXPERIMENTAL

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

Interventions

SEDA DEVICE

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

Cochlear Implant Users

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Tisch Hospital

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• David M. Landsberger

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David M. Landsberger

CONTACT

212-263-8455; David.landsberger@nyulangone.com

Natalia Stupak

CONTACT

646-501-4153; Natalia.stupak@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 10, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)