Quality Control of CE-Certified Phonak Hearing Aids - 2016_06
18. juli 2016 oppdatert av: Sonova AG
Quality Control of CE-Certified Phonak Hearing Aids
A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of hearing participants to grant quality control prior to product launch.
The aim of the investigation series is to ensure zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems and to equivalent competitor devices.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Phonak Hearing Systems pass through different development and study stages.
At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner.
If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized.
Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials in the way as planned for this study ("phase of final inspection").
This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
Studietype
Intervensjonell
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Zürich
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Stäfa, Zürich, Sveits, 8712
- Sonova AG
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
- Good written and spoken (Swiss) German language skills
- Healthy outer ear
- Ability to fill in a questionnaire (p/eCRF) conscientiously
- Informed Consent as documented by signature
Exclusion Criteria:
- Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
- Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
- Limited ability to describe listening impressions/experiences and the use of the hearing aid
- Inability to produce a reliable hearing test result
- Massively limited dexterity
- Known psychological problems
- Central hearing disorders
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Zero-defect performance in daily life
Tidsramme: Four weeks
|
The data, serving as primary outcomes are collected in a series of home trials taking place between the lab trial appointments.
The zero-defect performance in daily life (that means: no interruptions, distortions, artefacts, feedback, system noise or other malfunctions) will be assessed with the aid of quantitative questionnaires.
The results are "Yes/No" replies and open-ended.
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Four weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Speech intelligibility in percent in a quiet listening situation
Tidsramme: Four weeks
|
The data, serving as secondary outcomes are collected in a series of lab appointments.
The speech intelligibility in quiet will be assessed with the aid of the german rhyme test "Einsilber-Reimtest nach von Wallenberg und Kollmeier" (WaKo).
The result is the speech intelligibility in percent.
Descriptive statistics will be executed in the form of determining the median and quartiles.
Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution.
A significance level of 5% is pursued.
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Four weeks
|
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Speech intelligility in noise as signal to noise ration in dB (dB SNR)
Tidsramme: Four weeks
|
The data, serving as secondary outcomes are collected in a series of lab appointments.
The speech intelligibility in noise will be assessed with the aid of the german Oldenburger sentence test.
The result is the signal to noise ratio in dB (dB SNR).
Descriptive statistics will be executed in the form of determining the median and quartiles.
Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution.
A significance level of 5% is pursued.
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Four weeks
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Initial first fit acceptance (pre-calculation) in lab
Tidsramme: One week
|
The data, serving other pre-specified outcomes are collected within the first lab appointment.
The acceptance of the initial first fit will be assessed with the aid of quantitative questions within an interview.
The results are points on a scale and open ended (e.g.
Question: Please rate the sound quality; Answer scale: bad, poor, fair, good, excellent) .
Descriptive statistics will be executed in the form of determining number of answers.
Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution.
A significance level of 5% is pursued.
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One week
|
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Real ear frequency responses of the hearing aids (Real Ear Measurements)
Tidsramme: One week
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The data, serving other pre-specified outcomes are collected within the first lab appointment.
The Real Ear Measurements (REMs) will be assessed with the aid of quantitative questions within an interview.
The results are frequency responses (magnitude and phase of the hearing aid output as a function of frequency).
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One week
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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
1. mai 2016
Primær fullføring (Faktiske)
1. juni 2016
Studiet fullført (Faktiske)
1. juli 2016
Datoer for studieregistrering
Først innsendt
31. mars 2016
Først innsendt som oppfylte QC-kriteriene
14. april 2016
Først lagt ut (Anslag)
15. april 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
19. juli 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. juli 2016
Sist bekreftet
1. juli 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Sonova2016_06
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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