Evaluating a Noise Reduction Algorithm With Cochlear Implant Users

DEVICE

SEDA

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.