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The purpose of this evaluation is to receive the greatest benefit of new custom made hearing product technology and shell modification for the end customer and to continual improve the custom made hearing products.
This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa.
The purpose of the studies is to evaluate the strengths and weaknesses of new custom product development in comparison to existing/old products. The results should promote the custom product development, to provide a maximum of benefit and wearing comfort to the hearing aid user.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hearing Device Type A | Active Comparator | In the ear (ITE) hearing aid, 1-3 weeks wearing |
|
| Hearing Device Type B | Experimental | In the ear (ITE) hearing aid, 1-3 weeks wearing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hearing aid (MD class IIa) - ITE, BTE, RIC | Device | Hearing aid means any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective measurement of speech intelligibility related to the intervention. | SNR (speech to noise ratio) in decibel. | 5 years |
| Objective measurement of the transfer function related to the intervention. | REM (real ear measurement) in decibel. | 5 years |
| Objective measurement from the position of the outer ear related to the test subject. | Measurement in degree. | 5 years |
| Objective measurement from the size of the outer ear related to the test subject. | Measurement in micron. | 5 years |
| Objective measurement of humidity in the ear canal related to the test subject and the intervention. | Measurement in percent. | 5 years |
| Objective measurement of temperature in the ear canal related to the test subject and the intervention. | Measurement in degree centigrade. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective rating of the intervention via questionnaire. | Ordinal scale | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jana-Kosima Schwarzlos, B.Sc. | Contact | +41 58 928 0101 | JanaKosima.Schwarzlos@sonova.com |
| Name | Affiliation | Role |
|---|---|---|
| Jana-Kosima Schwarzlos, B.Sc. | Switzerland, Sonova AG, CH-8712 Staefa, Zurich | 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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| 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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|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |