Quality Control of CE-Certified Phonak Hearing Aids - 2016_37

Study Overview
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Brief Summary
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A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss 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.

Detailed Description
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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).

Official Title
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Quality Control of CE-Certified Phonak Hearing Aids - 2016_37

Conditions
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Hearing Loss, Bilateral Sensorineural, Progressive

Intervention / Treatment
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* Device: Hearing Aid (Successor of Phonak Virto V)
* Device: Hearing Aid (Phonak Virto V)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Phonak Virto V and the successor of Phonak Virto V will be fitted to the participants individual hearing loss.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Successor of Phonak Virto V<br>The successor of Phonak's Virto V will be fitted to the participants individual hearing loss. | Device: Hearing Aid (Successor of Phonak Virto V)<br>* The successor of Phonak's In-The-Ear (ITE) hearing aid Virto V will be fitted to the participants individual hearing loss.<br>|
| Active Comparator: Phonak Virto V<br>Phonak Virto V will be fitted to the participants individual hearing loss. | Device: Hearing Aid (Phonak Virto V)<br>* Phonak's In-The-Ear (ITE) hearing aid Virto V will be fitted to the participants individual hearing loss.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech intelligibility in noise as signal to noise ratio in dB (dB SNR) | The data, serving as primary outcomes are collected in a series of lab appointments. The speech intelligibility in noise will be assessed with the aid of the german Oldenburg 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. | Three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech intelligibility in percent in a quiet listening situation | 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. | One week | 
| Zero-defect performance in daily life | The data, serving as secondary 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. | Three weeks |