Hearing Loss
Conditions
Brief summary
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.
Interventions
DEVICEPhonak's equivalent newly developped power BTE
DEVICEEquivalent competitor device
Sponsors
Sonova AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech intelligibility in quiet. Discrimination [%] | One week. | 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. |
| Speech intelligibility in noise. Speech Reception Threshold [dB SNR] | One week. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phoneme Perception Test, test no. 1. | Four weeks | 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. |
| Phoneme Perception Test, test no. 2. | Four weeks | 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. |
| Phoneme Perception Test, test no. 3. | Four weeks | 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. |
| Diary to describe hearing impressions in everyday life | Six weeks | 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. |
Countries
Switzerland
Outcome results
None listed