Quality Control of CE-Certified Phonak Hearing Aids - 2016_06
18 juli 2016 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Interventionell
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Zürich
-
Stäfa, Zürich, Schweiz, 8712
- Sonova AG
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Zero-defect performance in daily life
Tidsram: 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.
|
Four weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Speech intelligibility in percent in a quiet listening situation
Tidsram: 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.
|
Four weeks
|
|
Speech intelligility in noise as signal to noise ration in dB (dB SNR)
Tidsram: 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.
|
Four weeks
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Initial first fit acceptance (pre-calculation) in lab
Tidsram: 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.
|
One week
|
|
Real ear frequency responses of the hearing aids (Real Ear Measurements)
Tidsram: One week
|
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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2016
Primärt slutförande (Faktisk)
1 juni 2016
Avslutad studie (Faktisk)
1 juli 2016
Studieregistreringsdatum
Först inskickad
31 mars 2016
Först inskickad som uppfyllde QC-kriterierna
14 april 2016
Första postat (Uppskatta)
15 april 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
19 juli 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 juli 2016
Senast verifierad
1 juli 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Sonova2016_06
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