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Noise Reduction With Hearing Aids

7. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • New York
      • New York, New York, Forente stater, 10016
        • NYU Langone Health

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm
All participants will complete the testing using the SEDA-HA algorithm.
Enhet: 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.
Eksperimentell: 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.
Enhet: Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm
All participants will complete the testing using the SEDA-HA algorithm.
Enhet: 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.
Eksperimentell: 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.
Enhet: Speech Enhancement using Decomposition Approach-Hearing Aid (SEDA-HA) algorithm
All participants will complete the testing using the SEDA-HA algorithm.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of words repeated with SEDA
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

NYU Langone Health

Samarbeidspartnere

National Institute on Deafness and Other Communication Disorders (NIDCD)

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. september 2029

Studiet fullført (Antatt)

1. september 2029

Datoer for studieregistrering

Først innsendt

7. juli 2026

Først innsendt som oppfylte QC-kriteriene

7. juli 2026

Først lagt ut (Faktiske)

13. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 25-01343
  • 5SB1DC018761-05 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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