Bilateral Sensorineural Hearing LossNCT07700043
Noise Reduction With Hearing Aids
A study testing Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm and Hearing aid (HA) prototype with SEDA-HA algorithm in people with Bilateral Sensorineural Hearing Loss, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Bilateral Sensorineural Hearing Loss
- What is being tested?
- Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm and Hearing aid (HA) prototype with SEDA-HA algorithm
- 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
- Sep 2026to Sep 2029
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
David Landsberger, Ph.D. contact
About this study
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.
- Conditions
- Bilateral Sensorineural Hearing Loss
- Being tested
- Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm, Hearing aid (HA) prototype with SEDA-HA algorithm
- Keywords
- Hearing aid, Hearing loss, Cochlear Implant, CI
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithmDevice
All participants will complete the testing using the SEDA-HA algorithm.
Hearing aid (HA) prototype with SEDA-HA algorithmDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mild hearing loss | Experimental | 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. Receives: Device: Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm; Device: Hearing aid (HA) prototype with SEDA-HA algorithm |
| Moderate hearing loss | Experimental | 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. Receives: Device: Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm; Device: Hearing aid (HA) prototype with SEDA-HA algorithm |
| Severe hearing loss | Experimental | 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. Receives: Device: Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm; Device: Hearing aid (HA) prototype with SEDA-HA algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of words repeated with SEDA
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.
Measured: Day 1 (up to 4 hours)
Number of words repeated without SEDA
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.
Measured: Day 1 (up to 4 hours)
Number of participants who preferred SEDA-on condition
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".
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Sensorineural Hearing LossStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- 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 Landsberger, Ph.D., Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700043
- Sponsor's protocol ID
- 25-01343
- Other IDs
- 5SB1DC018761-05
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- 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 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noise Reduction With Hearing Aids
- ClinicalTrials.gov ID
- NCT07700043
- Acronym / sponsor ID
- 25-01343
- Conditions
- Bilateral Sensorineural Hearing Loss
- Keywords
- Hearing aid, Hearing loss, Cochlear Implant, CI
- Study type
- Interventional
- Recruitment status
- Not yet 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
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 13 Jul 2026 (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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild hearing loss | Experimental | Device: Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm, Device: Hearing aid (HA) prototype with SEDA-HA algorithmSpeech 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. |
| Moderate hearing loss | Experimental | Device: Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm, Device: Hearing aid (HA) prototype with SEDA-HA algorithmSpeech 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. |
| Severe hearing loss | Experimental | Device: Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm, Device: Hearing aid (HA) prototype with SEDA-HA algorithmSpeech 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
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 |
|---|---|---|
| Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithmAll participants will complete the testing using the SEDA-HA algorithm. | Device | Mild hearing loss, Moderate hearing loss, Severe hearing loss |
| Hearing aid (HA) prototype with SEDA-HA algorithmThe 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. | Device | Mild hearing loss, Moderate hearing loss, Severe hearing loss |
Primary outcome
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.
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.
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".
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 13 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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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 Landsberger, Ph.D. contact
David Landsberger, Ph.D. 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 Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm and Hearing aid (HA) prototype with SEDA-HA algorithm in people with Bilateral Sensorineural Hearing Loss, 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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 13 Jul 2026. 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 Natalia Stupak (646-501-4153, Natalia.stupak@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of words repeated with SEDA (time frame: Day 1 (up to 4 hours)). The study lists 3 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 13 Jul 2026.