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Noise Reduction With Hearing Aids

7 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • New York
      • New York, New York, Verenigde Staten, 10016
        • NYU Langone Health

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm
All participants will complete the testing using the SEDA-HA algorithm.
Apparaat: 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.
Experimenteel: 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.
Apparaat: Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm
All participants will complete the testing using the SEDA-HA algorithm.
Apparaat: 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.
Experimenteel: 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.
Apparaat: Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm
All participants will complete the testing using the SEDA-HA algorithm.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of words repeated with SEDA
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

NYU Langone Health

Medewerkers

National Institute on Deafness and Other Communication Disorders (NIDCD)

Onderzoekers

  • Hoofdonderzoeker: David Landsberger, Ph.D., NYU Langone Health

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 september 2029

Studie voltooiing (Geschat)

1 september 2029

Studieregistratiedata

Eerst ingediend

7 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 juli 2026

Eerst geplaatst (Werkelijk)

13 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

7 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 25-01343
  • 5SB1DC018761-05 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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