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A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired. These sound changing principles are enabled by respective hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Staefa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sound Processing Principle 1 | Active Comparator | Sound Processing Principle 1 will be applied in the hearing aid. |
|
| Sound Processing Principle 2 | Experimental | Sound Processing Principle 2 will be applied in the hearing aid. |
|
| Sound Processing Principle 3 | Experimental | Sound Processing Principle 3 will be applied in the hearing aid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phonak Audéo L2M with Sound Processing Principle 1 | Device | Compensation of a hearing loss with Sound Processing Principle 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Speech Intelligibility in Noise | The speech intelligibility in noise with the three different sound processing principles will be assessed with the aid of the Oldenburg Sentence Test. The result will be shown in dB (decibel) SRT (Speech Reception Threshold). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sound Quality - Overall | The overall sound quality of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (bad) to 10 (excellent). | 16 weeks |
| Loudness - Laboratory |
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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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Each participant will be treated with sound principle 1, 2 and 3 in a crossover design.
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The participant's will not know which intervention will be applied.
| Phonak Audéo L2M with Sound Processing Principle 2 | Device | Compensation of a hearing loss with Sound Processing Principle 2. |
|
| Phonak Audéo L2M with Sound Processing Principle 3 | Device | Compensation of a hearing loss with Sound Processing Principle 3. |
|
The loudness of sounds with the three different sound processing principles will be assessed in laboratory with the aid of a MUSHRA (Multi-Stimulus Test with Hidden Reference and Anchor) test. The results are ratings on a numeric scale, ranging from 0 (very soft), 50 (just right) to 100 (very loud). |
| 8 weeks |
| Loudness - Daily Life | The loudness of sounds with the three different sound processing principles will be assessed in daily life with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (very soft) to 10 (very loud). | 16 weeks |
| Clarity - Daily Life | The clarity of sounds with the three sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (very unclear) to 10 (very clear). | 16 weeks |
| Preferred Sound Processing Principle | The preferred sound processing principle will be assessed with the aid of a questionnaire. The results will be a ranking, ranging from 1 (most preferred) to 3 (least preferred). | 16 weeks |
| Naturalness - Daily Life | The sound quality with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (unnatural) to 10 (natural). | 16 weeks |
| Localization - Daily Life | The ability to localize sounds with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (not at all locatable) to 10 (very well locatable). | 16 weeks |
| Reverberation - Daily Life | The reverberation of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (not at all reverberant) to 10 (very reverberant). | 16 weeks |
| Satisfaction - Overall in Daily Life | The overall satisfaction in daily life with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (very dissatisfied) to 10 (very satisfied). | 16 weeks |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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