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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 usability, 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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Line extension of the Phonak Audéo B hearing aid | Experimental | The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss. |
|
| Phonak Audéo B hearing aid | Active Comparator | Phonak Audéo B will be fitted to the participants individual hearing loss. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Line extension of the Phonak Audéo B product family | Device | The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Usability (phone calls) | The data, serving as primary outcomes are collected in a lab appointment. The participants will be asked to accept, reject and hang up phone calls with the aid of the push button of the hearing aid. The usability will be subjectively assessed by the participants and additionally by the investigators on given scales. Descriptive statistics will be executed. 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simone Ebbing, B.Sc. | Sonova AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sonova AG | Stäfa | Canton of Zurich | 8712 | Switzerland |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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Phonak Audéo B and a line extension of the Phonak Audéo B hearing aid product family will be fitted to the participants individual hearing loss.
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| Phonak Audéo B | Device | Phonak Audéo B will be fitted to the participants individual hearing loss. |
|
| Three weeks |
| Speech intelligibility in noise as signal to noise ratio in dB (dB SNR) | 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 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. | One week |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |