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| Name | Class |
|---|---|
| Hoerzentrum Oldenburg | UNKNOWN |
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The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities.
This is a comparative study which is conducted monocentric at Hoerzentrum Oldenburg, Germany. The focus is to test a released hearing aid and compare this to the subject's own hearing aids with a minimum of 18 adult subjects with mild-to-moderate sensorineural hearing impairement. The subjects, all native German speakers, have 1 appointment of 1-2 hours including a fitting procedure with real-ear measurements and selected standard speech tests and tests of basic hearing-aid related task.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparison of Study Devices with Own devices | Other | within subject design: compare Signia Insio 7IX ITC and Signia Silk 7IX to subjects' own hearing aids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-the-Ear Hearing Aid | Device | Custom In-the-Ear hearing aid. Form Factor In the Canal (ITC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oldenburg Sentence Test | The Oldenburg Sentence Test (OLSA) is an audiometric test for determining the speech recognition threshold in quiet and in noise. Sentences of the form name - verb - numeral - adjective - noun are used as speech material. The sequence of words is a random combination from an inventory of 50 words in total. The design of the test prevents memorization of the sentences, so the OLSA can be repeated as often as desired. | Estimated Time Frame 2 weeks (Test conducted at second lab session). |
| Measure | Description | Time Frame |
|---|---|---|
| Freiburger Monosyllabic Speech Test | To investigate speech intelligibility (SI) performance for speech at 65dB in a quiet listening situation, the Freiburger monosyllabic speech test is used which is still the gold standard for Hearing Care Professionals (HCPs) in Germany. | Estimated Time Frame 2 weeks (Test conducted at second lab session). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hörzentrum Oldenburg gGmbH | Oldenburg | Germany | 26129 | Germany |
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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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| Own hearing aid | Device | subjects' own hearing aids, any brand, any model |
|
| In-the-Ear Hearing Aid | Device | Instant Fit Hearing Aid, Form Factor CIC |
|
| Match-to-Target | Investigate how close the study hearing aids fitted with the fitting software to NAL-NL2 Targets match the postulated targets, as measured in-situ with real-ear measurements | Day 1 (Fitting procedure with real-ear measurements is done at first lab session) |
| Basic user need documentation | Investigate ability to carry out different hearing-aid related tasks with the test hearing aids documenting if the subjects can carry out the task without support / with support of IFU / with support of Audiologist / Not at all. | One session of approximately 2 hours. |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |