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A methodical evaluation of sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and 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). 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 |
|---|---|---|---|
| Hearing aid standard NR_1 | Active Comparator | Hearing Aid with standard noise reduction (NR) serves as reference condition |
|
| Hearing Aid with NR_2 | Experimental | NR_2: Noise reduction principle 2 |
|
| Hearing Aid with NR_3 | Experimental | NR_3: Noise reduction principle 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing Aid with standard noise reduction (NR_1) | Device | Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 manual programs (ensures exact same hearing loss compensation for each intervention). Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The active comparator condition is the state of the art Noise Reduction principle to mimic the natural directivity of the outer ear. |
| Measure | Description | Time Frame |
|---|---|---|
| Own Voice Level | Changes to the participants' own voice level (RMS in dB) during a conversation in noise in the laboratory will be recorded in each interventional condition. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Interpersonal distance | Changes to the participants' interpersonal distance (in m) during a conversation in noise in the laboratory will be measured in each interventional condition. | 3 weeks |
| Qualitative interview form |
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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 | Stäfa | 8712 | Switzerland |
|
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Each participant will be treated with each sound changing principle in a randomized order.
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|
| Hearing Aid with NR_2 | Device | Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 manual programs (ensures exact same hearing loss compensation for each intervention). Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality. |
|
| Hearing Aid with NR_3 | Device | Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 manual programs (ensures exact same hearing loss compensation for each intervention). Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality. |
|
A qualitative questionnaire with predefined questions to gather individual perceptions regarding the 3 interventional conditions during a conversation in noise in the laboratory. The data collected from this questionnaire are scores on a rating scale from "0" (worst) to "5" (best) in increments of 1.
| 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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