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This is a prospective and monocentric clinical investigation, non-interventional and non-randomized. The overall goal of this clinical study is to generate additional clinical data confirming the safety and efficacy of the remote programming functionality of Target CI version 1.5 and the AB Remote Support app. Hearing outcomes are expected to be similar whether a study subject's sound processor is programmed in the traditional method in the audiologist's office or whether programming is performed via remote fitting. Therefore, the study uses a non-inferiority design to determine whether sentence recognition in noise is no worse with remote fitting than in an in-office setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Unilateral users |
| |
| Group 2 | Bilateral users |
| |
| Group 3 | Bimodal users |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Target CI v1.5 remote programming | Device | Use of the remote programming function of Target CI v1.5 and the AB remote support application |
|
| Measure | Description | Time Frame |
|---|---|---|
| 50% SRT measured as signal to noise ratio in DB (French Matrix test in noise) | The primary efficacy objective is to demonstrate that speech recognition in noise after remote fitting is no worse than speech recognition in noise after in-office fitting. | one-month chronic use of remotely fitted sound processor |
| Measure | Description | Time Frame |
|---|---|---|
| Score in the Lafon phoneme test in quiet | The secondary efficacy objective is to demonstrate that speech recognition in quiet after remote fitting is no worse than speech recognition in quiet after in-office fitting. | one-month chronic use of remotely fitted sound processor |
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Inclusion Criteria:
Ability to provide informed consent
Ability to give feedback on hearing impressions
Aged 18 years of age or older
Implanted with a HiResolution Bionic Ear System (HiRes 90K or HiRes 90K Advantage or HiRes Ultra or HiRes Ultra 3D) on at least one side
Minimum of six months of cochlear implant experience
Minimum of one month experience with a Naída CI M or Sky CI M sound processor
Fluent in French language
Ability to be tested via speech perception test in noise
Smartphone user
Exclusion Criteria:
Pregnancy and breast-feeding are not exclusion criteria.
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Advanced Bionics adults CI users
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupement Hospitalier Pitié Salpêtrière | Recruiting | Paris | 75013 | France |
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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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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |