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| Name | Class |
|---|---|
| MED-EL Elektromedizinische Geräte GesmbH | INDUSTRY |
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In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. Both the standard frequency-band distribution and anatomy-based fitting will be used to compare outcomes.
In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9. In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9. The performance with anatomy-based fitting is assessed by comparing performance with the CI in these two groups over time.
The third group constitutes the within-subject design. These subjects are both fitting using the standard frequency-band distribution and the anatomy-based frequency distribution in MAESTRO 9. So, subjects will have both study maps on their audio processor throughout the whole study. They will have to change weekly between both fittings: standard fitting and anatomy-based fitting. Here, the performance with anatomy-based fitting is assessed by comparing performance with standard fitting and anatomy-based fitting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard fitting | Placebo Comparator | The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9 |
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| Anatomy-based fitting | Experimental | In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9 |
|
| Within-subject design: Standard fitting + ABF | Experimental | The third group constitutes the within-subject design. These subjects are both fitting using the standard frequency-band distribution and the anatomy-based frequency distribution in MAESTRO 9. So, subjects will have both study maps on their audio processor throughout the whole study. They will have to change weekly between both fittings: standard fitting and anatomy-based fitting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anatomy-based fitting (ABF) | Procedure | MAESTRO 9 can display the tonotopic frequency of each individual electrode channel imported from OTOPLAN to further support fitting based on these measures. The audiologist can set a frequency-band distribution that is more closely aligned to the tonotopic frequency distribution as imported from OTOPLAN. |
| Measure | Description | Time Frame |
|---|---|---|
| Result from the speech test in noise (S0N0) | Speech perception evaluation with CI-only (MATRIX) with signal and noise in the same channel | Month 6 |
| Results from speech tests in noise with spatially separated loudspeakers | Speech perception evaluation with CI-only (MATRIX) with signal and noise in different channels | Month 6 |
| Result from the speech test in quiet (S0) | Speech perception evaluation with CI-only (disyllables) | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Results of quality of sound | Subjective results through Hearing Implant Sound Quality Index 19. Scores range 19-133 points. Higher scores mean a better outcome. | Month 6 |
| Results of quality of life in challenging situations |
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Inclusion Criteria:
Specific inclusion criteria for the possible study groups • Bilateral CI users: Bilateral CI implantation SONNET 2/RONDO3 audio processor on the first ear implanted
40% speech recognition a monosyllabic word Test in quiet at 65 dB SPL (last time tested) on the already implanted side
40% speech recognition in a sentence test in noise (10 dB SNR) on the already implanted side First activation of the already implanted side between 3 and 12 months prior to study inclusion
• Unilateral CI users: Unilateral CI implantation CI user with contralateral hearing ≥ 60 dB (PTA measured at 500, 1000, 2000, and 4000 Hz)
• SSD CI users: Unilateral CI implantation CI user with contralateral hearing ≤30 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) Interaural threshold gap ≥40 dB
• Bimodal CI users: Unilateral CI implantation Contralateral ear adequately fitted with a hearing aid CI user with contralateral hearing ≥30 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) CI user with contralateral hearing ≤55 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) Interaural threshold gap ≥15 dB
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis Lassaletta, PhD | Contact | 0034656898265 | llasaletta@salud.madrid.org | |
| Miryam Calvino, PhD | Contact | 0034646354267 | miryamcf@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Luis Lassaletta, PhD | Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de La Paz | Recruiting | Madrid | Madrid | 28046 | Spain |
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| Standard Fitting | Procedure | These group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9. |
|
| Standard fitting+ ABF | Procedure | Patients of this group are both fitting using the standard frequency-band distribution and the anatomy-based frequency distribution in MAESTRO 9. So, subjects will have both study maps on their audio processor throughout the whole study. They will have to change weekly between both fittings: standard fitting and anatomy-based fitting. Here, the performance with anatomy-based fitting is assessed by comparing performance with standard fitting and anatomy-based fitting. |
|
Subjective results through Listening effort questionnaire. Scores range 21-93 points. Higher scores mean a better outcome.
| Month 6 |