Hearing ImpairmentNCT05805384
Evaluating a Noise Reduction Algorithm With Cochlear Implant Users
A study testing SEDA in people with Hearing Impairment, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hearing Impairment
- What is being tested?
- SEDA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Anyone who is not a cochlear implant user or is aged under 12 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tisch Hospital
New York, New York, 10016
About this study
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
- Being tested
- SEDA
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEDADevice
Speech Enhancement using Dynamic thresholding Approach (SEDA) is a software algorithm that removes background noise.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SEDA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Up to Year 2 (Completion of Experiment 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Mar 2023
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing ImpairmentStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- David M. Landsberger, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805384
- Sponsor's protocol ID
- 22-00815
- Other IDs
- SB1DC018761
- Status last verified
- Dec 2025
- First submitted
- 23 Mar 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Noise Reduction Algorithm With Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT05805384
- Acronym / sponsor ID
- 22-00815
- Conditions
- Hearing Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear Implant Users | Experimental | Device: SEDAParticipants 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Anyone who is not a cochlear implant user or is aged under 12 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEDASpeech Enhancement using Dynamic thresholding Approach (SEDA) is a software algorithm that removes background noise. | Device | Cochlear Implant Users |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David M. Landsberger principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEDA in people with Hearing Impairment, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David M. Landsberger (212-263-8455, David.landsberger@nyulangone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Words Correctly Recognized in Noisy Conditions with SEDA NR (time frame: Up to Year 2 (Completion of Experiment 1.1)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.