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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. This is a pre-validation study, investigating optimized algorithms, features and functions. This will be a 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 |
|---|---|---|---|
| Successor of Phonak Audéo B-Direct | Experimental | The successor of Phonak Audéo B-Direct will be fitted to the participants individual hearing loss. |
|
| Phonak Audéo B-Direct | Active Comparator | The Phonak Audéo B-Direct will be fitted to the participants individual hearing loss. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Successor of Phonak Audéo B-Direct | Device | The successor of Phonak Audéo B-Direct will be fitted to the participants indivudal hearing loss. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous acceptance of the initial pre-calculation (first fit) | The data, serving as primary outcomes are collected in the first study appointment. The spontaneous acceptance of the initial pre-calculation (also called 'first fit') in regard to loudness and sound quality will be assessed with the aid of a systematic interview in lab. | One week |
| Measure | Description | Time Frame |
|---|---|---|
| Listening effort in noisy listening environment | The data, serving as secondary outcomes are collected in the second study appointment. The listening effort in noisy listening environments will be assessed under controlled conditions in lab with the aid of the Adaptive Categorial Listening Effort Scaling Test (ACALES). The result shows the listening effort on a scale from 'no effort - extreme effort' at different signal to noise ratios. |
| Measure | Description | Time Frame |
|---|---|---|
| TV streaming | The data, serving as other outcomes are collected within home trials with the test hearing aids, which take place between the weekly study appointments. The participants will be asked to assess the streamed signals in regard to any disturbing artefacts (e. g. fluctuation of volume or sound quality). In case that the participants experienced such artefacts, they will be asked to rate how bothersome these artefacts were (on a 10-point scale from 'not at all - extremely'). These ratings will be aggregated to arrive at one reported value. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sonova AG | Stäfa | Canton of Zurich | 8712 | Switzerland |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Phonak Audéo B-Direct | Device | The Phonak Audéo B-Direct will be fitted to the participants individual hearing loss. |
|
| One week |
| Speech intelligibility in noisy listening environment | The data, serving as secondary outcomes are collected in the third study appointment. The speech intelligibility in noise will be assessed with the aid of the german Oldenburg sentence test (OLSA) under controlled conditions in lab. The result is the signal to noise ratio in dB (dB SNR). | One week |
| Three weeks |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |