Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Evaluation of the Clinical Benefit of a Transmitter for Contralateral Routing of Signals (CROS)

8. april 2022 opdateret af: Sonova AG
This study will evaluate the clinical benefit of a transmitter for contralateral routing of signals. The benefit will be evaluated in noisy environments regarding speech intelligibility when the CROS system is adjusted to different microphone settings. Additionally, data regarding overall system stability, crash reboot rate, sound quality and connectivity will be obtained over a period of time to validate the CROS system in combination with smartphone and accessories. This study is a confirmatory study.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Unilateral Hearing Loss (UHL) can be defined as any degree of permanent hearing loss on one ear with normal hearing in the opposite ear. Unilateral hearing loss can be debilitating associated with audiological, psychosocial and educational challenges. Audiological challenges include the reduced ability to localize sounds, reduced awareness on the unaidable side and difficulties hearing in noise or at a distance.

One solution for unaidable UHL is Contralateral Routing of Signals (CROS) and Bilateral Contralateral routing of signals (BiCROS) using a so- called CROS transmitter together with a hearing aid.

The rationale for this clinical investigation is to collect clinical data with a rechargeable CROS transmitter to evaluate the benefits of a BiCROS fitting compared to the alternative treatment option, the monaural hearing aid fitting, and to no treatment in noisy listening situations.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

23

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Schweiz
    • Zürich
      • Stäfa, Zürich, Schweiz, 8712
        • Sonova AG

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • hearing impaired adults, with & w/o hearing aids (experiences)
  • good written and spoken (Swiss) German language skills
  • ability to fill in a questionnaire conscientiously
  • informed consent as documented by signature
  • asymmetric hearing loss: one unaidable ear (min. N6 hearing loss) / the other ear with N3 or N4 hearing loss
  • availability of Smartphone
  • availability of TV or Tablet
  • ability to operate and handle the investigational device
  • ability to describe listening impressions/experiences and the use of the hearing aid
  • Ability to produce a reliable hearing test result

Exclusion Criteria:

  • Contraindications to the medical device:
  • aidable hearing loss on the intended CROS side
  • acute tinnitus (in either one ear and occurrence less than three months)
  • anatomical deformity of the CROS ear (e.g. absence of the auricle)
  • Known hypersensitivity or allergy to materials of the investigational device
  • any auricle deformities, that prevents secure placement of the (test) devices
  • no willingness to test the investigational device system
  • no willingness to test the investigational device system for at least 8h a day
  • Hint for psychological problems from investigators point of view
  • reported fluctuating hearing that could influence the test result
  • reported symptoms of vertigo and dizziness by participants

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Speech Intelligibility with CROS device

The focus of this study is on Speech Intelligibility (SI), evaluated by the Oldenburg Sentence test (OLSA), which measures a speech recognition threshold (SRT) in dB SNR (signal to noise ratio).

Therefore each participant will perform the tests with the experimental rechargeable CROS transmitter (CROS) in different interventions, like comparison to monaural fitting and unaided condition.

All participants will perform the same tests. The order of the intervention in the speech test is randomized, but will be performed in the same visit by each participant.
Andet: Tilstand uden hjælp

Ingen behandling, dvs. deltagerne er ikke udstyret med CROS-apparat og/eller høreapparat.

Ustøttet tilstand fungerer som kontrolindgreb.

Andet: BiCROS fitting
Each participant will be fitted with the experimental CROS device on the poorer, unaidable ear and with a compatible hearing device on the other ear.
Andet: Monaural fitting

Each participant will be fitted with a hearing aid on the better hearing ear and no device on the poorer, unaidable ear.

Monaural hearing aid fitting acts as control intervention.

Andet: CROS baseline

Each participant will be fitted with the experimental CROS device on the poorer, unaidable ear and with a compatible device on the other ear. The difference to the BiCROS condition is the setup of the microphones in the CROS device and the compatible hearing device.

This test condition is only tested for speech intelligibility in diffuse noise and acts as control intervention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Speech Intelligibility (SI) in noise (fix direction): BiCROS fitting vs. monaural hearing aid fitting
Tidsramme: 2 weeks

The primary objective of this clinical investigation is to evaluate whether a BiCROS fitting (better ear fitted with a hearing device, unaidable ear supplied with a CROS device) improves speech intelligibility in noise compared to a monaural fitting (just the aidable ear is supplied by a hearing aid), for adults with an asymmetric hearing loss, measured with the Oldenburg Sentence Test (OLSA). Results of the speech test will be the SRT (speech recognition threshold) in dB SNR (signal to noise ratio).

The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A).

The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 70 dB (A).
2 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
SI in noise (fix direction): BiCROS fitting vs. unaided
Tidsramme: 2 week

A secondary objective of this clinical investigation is to evaluate whether a BiCROS fitting improves speech intelligibility in noise compared to an unaided condition, for adults with an asymmetric hearing loss, measured with the Oldenburg Sentence Test (OLSA).

Results of the speech test will be the SRT (dB SNR). The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A).

The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 70 dB (A).
2 week
SI in diffuse noise: BiCROS fitting vs. monaural fitting
Tidsramme: 2 weeks

A secondary objective of this clinical investigation is to evaluate whether a BiCROS fitting improves speech intelligibility by at least 1 dB SNR for 50% SRT in diffuse noise, compared to a monaural hearing aid fitting.

The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A).

The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 70 dB (A).
2 weeks
SI in diffuse noise: BiCROS fitting vs. unaided
Tidsramme: 2 weeks

A secondary objective of this clinical investigation is to evaluate whether a BiCROS fitting improves speech intelligibility by at least 1 dB SNR for 50% SRT in diffuse noise, compared to an unaided condition.

The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A).

The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 70 dB (A).
2 weeks
SI in diffuse noise: BiCROS vs. CROS baseline fitting
Tidsramme: 2 weeks

A secondary objective of this clinical investigation is to evaluate whether a BiCROS fitting improves speech intelligibility in diffuse noise compared with a CROS baseline fitting. CROS baseline means a fitting of an additional program with different hearing instrument microphone setup.

The SI will be tested with the OLSA in diffuse noise. The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A).

The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 70 dB (A).
2 weeks
SI in diffuse noise: CROS baseline fitting vs. unaided
Tidsramme: 2 weeks

A secondary objective of this clinical investigation is to evaluate whether a CROS baseline fitting improves speech intelligibility in diffuse noise compared with an unaided condition.

The SI will be tested with the OLSA in diffuse noise. The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A).

The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 70 dB (A).
2 weeks
SI in diffuse noise: CROS baseline fitting vs. monaural fitting
Tidsramme: 2 weeks

A secondary objective of this clinical investigation is to evaluate whether a CROS baseline fitting improves speech intelligibility in diffuse noise compared with a monaural fitting.

The SI will be tested with the OLSA in diffuse noise. The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A).

The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 70 dB (A).
2 weeks
SP in diffuse noise: monaural fitting vs. unaided
Tidsramme: 2 weeks

A secondary objective of this clinical investigation is to evaluate whether a monaural fitting improves speech intelligibility in diffuse noise compared with an unaided condition.

The SI will be tested with the OLSA in diffuse noise. The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A).

The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 70 dB (A).
2 weeks
Evaluation of Sound quality
Tidsramme: 3 weeks

A secondary objective of this study is to evaluate the participant's satisfaction of the sound quality of the experimental CROS device by a subjective rating during a three-week home trial period.

Scale: very unsatisfied- unsatisfied- neither nor- satisfied- very satisfied
3 weeks
Evaluation of System stability
Tidsramme: 3 weeks

A secondary objective of this study is to evaluate the participant's satisfaction of the system stability of the experimental CROS device during a three-week home trial period.

The participant shall report, if there are artefacts audible: never/ 1-2 times a week/ 3-6 times a week/ daily
3 weeks
Evaluation of streaming
Tidsramme: 3 weeks

A secondary objective of this study is to evaluate the participant's satisfaction of the streaming sound quality of the experimental CROS device, by a subjective rating during a three-week home trial period.

Scale: very unsatisfied- unsatisfied- neither nor- satisfied- very satisfied
3 weeks
Evaluation of listening effort
Tidsramme: 3 weeks

A secondary objective is to evaluate the subjective listening effort in noise reported by the participant whilst wearing the experimental CROS device.

Scale: not at all - slightly - somewhat - moderately - very - extremely
3 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sonova AG

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. oktober 2021

Primær færdiggørelse (Faktiske)

14. marts 2022

Studieafslutning (Faktiske)

14. marts 2022

Datoer for studieregistrering

Først indsendt

22. oktober 2021

Først indsendt, der opfyldte QC-kriterier

22. oktober 2021

Først opslået (Faktiske)

3. november 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. april 2022

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SRF-377

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Tilstand uden hjælp

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Serbia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner