Quality Control of CE-Labelled Phonak Hearing Systems (Study Part: Sonova2015-00)

Study Overview
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Brief Summary
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The purpose of this study, which contains a series of successive study parts, is to methodically evaluate Phonak Hearing Systems on hard of hearing participants to grant quality control prior to each product launch.

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Phonak's equivalent newly developped power BTE
* Device: Equivalent competitor device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hearing impaired persons with and without (experience with) hearing aids Good written and spoken (Swiss) German language skills Healthy outer ear (without previous surgical procedures) Ability to fill in a questionnaire conscientiously Informed Consent as documented by signature Exclusion Criteria: Contraindications to the medical device 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Naida Q90-SP<br>Phonak's commercial power Behind-The-Ear (BTE) device, type 1. | Device: Phonak's equivalent newly developped power BTE<br> <br> Device: Equivalent competitor device<br> <br> |
| Active Comparator: Naida Q90-UP<br>Phonak's commercial power Behind-The-Ear (BTE) device, type 2. | Device: Phonak's equivalent newly developped power BTE<br> <br> Device: Equivalent competitor device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech intelligibility in quiet. Discrimination [%] | The data, serving as primary outcome, 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. | 
| Speech intelligibility in noise. Speech Reception Threshold [dB SNR] | The data, serving as primary outcome, 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 Speech Reception Threshold [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. | One week. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phoneme Perception Test, test no. 1. | Free field audiometry using narrow band high frequency signals to measure detection thresholds [dB]. 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 | 
| Phoneme Perception Test, test no. 2. | Free field audiometry using high frequency phonemes to capture their recognition thresholds [dB]. 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 | 
| Phoneme Perception Test, test no. 3. | Free field audiometry using high frequency phonemes to capture the subjects' distinction capabilities [confusion matrix]. 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 | 
| Diary to describe hearing impressions in everyday life | Subjects are asked to describe their subjective experiences in different listening situations, in daily life, with the aid of quantitative questionnaires. the results are Yes/No replies and open-ended. | Six weeks |