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The purpose of this study is to evaluate audio quality benefit for the patient implanted with a Cochlear or Otologics Carina implant with the new firmware (feedback canceller algorithm) whatever the patient environment is and to evaluate the functional gain and speech understanding benefit for the patient upon the firmware used (new and reference firmware). The new firmware aims to adapt automatically for feedback cancellation without prior calibration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Firmware N | Experimental | New feedback canceller algorithm |
|
| Firmware R | Active Comparator | Current feedback canceller algorithm (reference) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| feedback canceller algorithm (Firmware) | Device | The study consists of two phases. Phase 1: optimization of parameters of new feedback canceller algorithm. Phase 2: comparison of new and reference feedback canceller algorithms. |
| Measure | Description | Time Frame |
|---|---|---|
| Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire | 1 month | |
| Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire | 2 months | |
| Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire | 3 months | |
| Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in speech understanding assessed via speech audiometry in noise | 1 month | |
| Improvement in speech understanding assessed via speech audiometry in noise | 2 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stéphane Tringali, Prof | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Nord | Marseille | Bouches-du-Rhône | 13915 | France | ||
| Hôpital Edouard Herriot |
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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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| Improvement in speech understanding assessed via speech audiometry in noise |
| 3 months |
| Improvement in speech understanding assessed via speech audiometry in noise | 4 months |
| Lyon |
| Rhône |
| 69003 |
| France |
| CHU Lyon Sud | Pierre-Bénite | Rhône | 69495 | France |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |