Quality Control of CE-Certified Phonak Hearing Aids - 2015_03

Study Overview
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Brief Summary
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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.

Official Title
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Quality Control of CE-Certified Phonak Hearing Aids

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Hearing Aid (Phonak Audéo V90-13)
* Device: Hearing Aid (Successor of Phonak Audéo V90-13)


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 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

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phonak Audéo V90-13<br>The Phonak Audéo V90-13 will be fitted to the participants individual hearing loss. | Device: Hearing Aid (Phonak Audéo V90-13)<br>* Phonak's Receiver-In-the-Canal (RIC) hearing aid Audéo V90-13 will be fitted to the participants individual Hearing loss.<br>|
| Experimental: Successor of Phonak Audéo V90-13<br>The successor of Phonak Audéo V90-13 will be fitted to the participants individual hearing loss. | Device: Hearing Aid (Successor of Phonak Audéo V90-13)<br>* The successor of Phonak's Receiver-In-the-Canal (RIC) hearing aid Audéo V90-13 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 percent in a quiet listening situation | The data, serving as primary 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech intelligibility in percent in a noisy listening situation | 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 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 |