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The study is a feasibility, prospective, repeated-measures, multi-country, multi-centre, study of the Mobile Research App to measure and validate speech perception endpoints in adult cochlear implant recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delivery of speech perception materials in-clinic using the Mobile Research App (MRA) | Experimental | Cochlear implant recipients will participate in this arm (sub-investigation AI5841A). |
|
| Delivery of speech perception materials in-clinic and at home using the Mobile Research App (MRA) | Experimental | Cochlear implant and hearing aid recipients will participate in this arm (sub-investigation AI5841B). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Research App (MRA) | Device | The MRA (research tool) is a platform used for the delivery of speech perception material in-clinic outside the sound booth or in the home of the hearing-impaired recipients. The MRA speech testing module delivers speech material via streaming to the single implanted ears of cochlear implant recipients. The recipient listens to the speech material and responds with what was heard via the app. Speech is streamed via Bluetooth from the iOS device to the sound processor of the CI-recipient. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent correct performance for the test and retest runs of speech perception ability | To determine if test-retest reliability with a correlation greater than or equal to 0.8 can be achieved for speech perception ability measured on the MRA outside the sound booth, percent correct performance for the test and retest runs of the speech perception ability will be compared. Scoring: Percentage correct Range: 0-100%, higher scores equal better performance | 1 day - immediately post screening. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Geert De Ceulaer | Contact | +32486893006 | gdeceulaer@cochlear.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Research and Technology Labs | Completed | Lone Tree | Colorado | 80124 | United States | |
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|
| SOC/validated delivery of the speech perception test material | Other | This involves the delivery of speech perception test material in the sound booth in a clinic. |
|
| HEARnet Clinical Studies |
| Active, not recruiting |
| Melbourne |
| Victoria |
| 3053 |
| Australia |
| European Institute for Otorhinolaryngology (EIORL) ENT department Sint-Augustinus Antwerp | Recruiting | Antwerp | Antwerp | 2610 | Belgium |
|
| Hoorzorg van Looveren | Recruiting | Wommelgem | Antwerp | 2160 | Belgium |
|
| 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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