Noise Reduction With Hearing Aids

July 7, 2026 updated by: NYU Langone Health
The purpose of this study is to use an optimized version of the SEDA algorithm (SEDA-HA) for hearing aids to evaluate the benefit for listeners with varying degrees of hearing loss in realistic environments and evaluate its impact on speech perception and sound quality. The primary objective is to evaluate performance with and without the SEDA-HA algorithm on speech perception and speech reception tasks. The secondary objective is to evaluate performance of and experience with SEDA-HA integrated into a portable hearing aid prototype in the laboratory and in real-world situations outside the laboratory.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 16 years of age and older
  • Bilateral sensorineural hearing loss. Hearing loss will be diagnosed as sensorineural by an air-bone gap of no more than 10 dB averaged across 0.5, 1, 2, and 3 kHz and Type A tympanograms.
  • Mild, moderate, or severe hearing loss. Hearing loss classification will be dependent on 4-frequency pure tone average (PTA, 0.5, 1, 2 and 4kHz) in the test ear. The mild group will have a PTA of 25-40 dB HL; moderate group will have a PTA of 41-60 dB HL; the severe group will have a PTA of 61-90 dB HL.
  • Be willing and able to provide consent.

Exclusion Criteria:

  • under 16 years of age
  • Participants with conductive or mixed hearing loss (i.e. have more than a 10 dB air-bone gap averaged across 0.5, 1, 2, and 3 kHz or tympanograms other than Type A)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mild hearing loss
Speech reception and speech perception will be measured in the presence of various types of background noise with and without the use of the SEDA-HA algorithm. Only participants ages 18 and older in this group will have the option to evaluate SEDA-HA integrated into a portable hearing aid prototype in a take-home trial.
Device: Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm
All participants will complete the testing using the SEDA-HA algorithm.
Device: Hearing aid (HA) prototype with SEDA-HA algorithm
The study device is a non-invasive, acoustic hearing aid prototype developed by York Sound. Participants ages 18 and older will then take-home the HA prototype to begin the at home protocol for 30 days.
Experimental: Moderate hearing loss
Speech reception and speech perception will be measured in the presence of various types of background noise with and without the use of the SEDA-HA algorithm. Only participants ages 18 and older in this group will have the option to evaluate SEDA-HA integrated into a portable hearing aid prototype in a take-home trial.
Device: Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm
All participants will complete the testing using the SEDA-HA algorithm.
Device: Hearing aid (HA) prototype with SEDA-HA algorithm
The study device is a non-invasive, acoustic hearing aid prototype developed by York Sound. Participants ages 18 and older will then take-home the HA prototype to begin the at home protocol for 30 days.
Experimental: Severe hearing loss
Speech reception and speech perception will be measured in the presence of various types of background noise with and without the use of the SEDA-HA algorithm. Only participants ages 18 and older in this group will have the option to evaluate SEDA-HA integrated into a portable hearing aid prototype in a take-home trial.
Device: Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm
All participants will complete the testing using the SEDA-HA algorithm.
Device: Hearing aid (HA) prototype with SEDA-HA algorithm
The study device is a non-invasive, acoustic hearing aid prototype developed by York Sound. Participants ages 18 and older will then take-home the HA prototype to begin the at home protocol for 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of words repeated with SEDA
Time Frame: Day 1 (up to 4 hours)
Participant will listen to an IEEE (IEEE Subcommittee, 1969) sentence and repeat all the words they hear. The process will be repeated for 10 sentences in each listening condition. Background noise will consist of one of five noise types (Babble, White Gaussian, Speech-Shaped, Restaurant, and Traffic) and one of five SNRs (-4, -2, 0, 3, and 6 dB). Each listening condition will be evaluated with and without SEDA, in an order that is randomized across participants.
Day 1 (up to 4 hours)
Number of words repeated without SEDA
Time Frame: Day 1 (up to 4 hours)
Participant will listen to an IEEE (IEEE Subcommittee, 1969) sentence and repeat all the words they hear. The process will be repeated for 10 sentences in each listening condition. Background noise will consist of one of five noise types (Babble, White Gaussian, Speech-Shaped, Restaurant, and Traffic) and one of five SNRs (-4, -2, 0, 3, and 6 dB). Each listening condition will be evaluated with and without SEDA, in an order that is randomized across participants.
Day 1 (up to 4 hours)
Number of participants who preferred SEDA-on condition
Time Frame: Day 30
The hearing aid prototype will feature two buttons "P1" and "P2", which correspond to the SEDA-on and SEDA-off conditions. Subjects will be asked if they prefer "P1" or "P2".
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: David Landsberger, Ph.D., NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-01343
  • 5SB1DC018761-05 (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 will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: David.Landsberger@nyulangone.org . The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

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.org To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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