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An exploratory investigation of gain precalculation principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These gain precalculation principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and assess strength and weaknesses of these gain precalculation principles in terms of speech intelligibility to determine their application in hearing instruments (Phase of development). Objective laboratory measurements as well as subjective ratings 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 Stäfa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Competitor device, hearing aid with standard gain precalculation principle | Active Comparator | Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The active comparator condition is the state of the art hearing aid gain precalculation from a competitor device. |
|
| Hearing aid with gain precalculation principle 1 | Experimental | Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The experimental conditions vary in their parametrization to result in different degrees of added amplification. |
|
| Hearing aid with gain precalculation principle 2 | Experimental | Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The experimental conditions vary in their parametrization to result in different degrees of added amplification. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Competitor device, hearing aid with standard gain precalculation principle | Device | Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The active comparator condition is the state of the art hearing aid gain precalculation from a competitor device. |
| Measure | Description | Time Frame |
|---|---|---|
| Speech intelligibility | Speech intelligibility in % will be assessed with a monosyllabic word recognition test for each of the interventional conditions | From enrollment to the end of treatment at 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative ratings on naturalness | Sound Signals will be rated in terms of naturalness on a scale from 0 - 100 in increments of 1 for each interventional condition | From enrollment to the end of treatment at 3 weeks |
| Qualitative ratings on loudness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian Griepentrog | Contact | 004158928 | 8676 | sebastian.griepentrog@sonova.com |
| Name | Affiliation | Role |
|---|---|---|
| Josephine Hollenbach | Sonova AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sonova AG | Recruiting | Stäfa | 8712 | Switzerland |
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Each participant will be treated with each gain precalculation principle in a randomized order
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|
| Hearing aid with gain precalculation principle 1 | Device | Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The experimental conditions vary in their parametrization to result in different degrees of added amplification. |
|
| Hearing aid with gain precalculation principle 2 | Device | Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The experimental conditions vary in their parametrization to result in different degrees of added amplification. |
|
Sound Signals will be rated in terms of perceived loudness on a scale from 1 - 5 in increments of 1 for each interventional condition
| From enrollment to the end of treatment at 3 weeks |
| Qualitative ratings on own voice quality | Own voice will be rated in terms of perceived bothersomeness on a scale from 1 - 5 in increments of 1 for each interventional condition | From enrollment to the end of treatment at 3 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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| ID | Term |
|---|---|
| D006310 | Hearing Aids |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012682 | Sensory Aids |
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