Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound processors associated with acoustic earhooks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Freiburger Monosyllabic Word Recognition Score in Quiet | Percent correct in the Freiburger Monosyllabic Word test | The Freiburger monosyllabic word test is performed 12 months after device activation |
| Measure | Description | Time Frame |
|---|---|---|
| Hochmair-Desoyer Schultz and Moser (HSM) Sentence Score or Oldenburger Sentence Test (OlSa) Recognition Score in Quiet | Percent correct in either the HSM sentence test or the Oldenburger sentence test (score from 0 to 100%) | The test (HSM or OlSa) is performed 12 months after device activation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
The studied population consists of all CI users implanted with a HiRes Ultra or HiRes Ultra 3D SlimJ between January 2017 and August 2022 and using an acoustic earhook at the Medical University of Hannover in Germany (MHH)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andreas Büchner | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Hochschule Hannover | Hanover | D-30625 | Germany |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | EAS CI Users | adult EAS CI users implanted with an Ultra or Ultra 3D SlimJ implant between 2018 and 2023 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EAS CI Users | adult Electro-Acoustic Stimulation (EAS) Cochlear Implants (CI) users implanted with an Ultra or Ultra 3D SlimJ implant between 2018 and 2023 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at implantation |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Freiburger Monosyllabic Word Recognition Score in Quiet | Percent correct in the Freiburger Monosyllabic Word test | Results of the Freigburger test are available for 23 subjects at 12m. Although 55 patients were included in this retrospective study, data at 12 months is not available for all the subjects. | Posted | Mean | Standard Deviation | Percent correct in the Freiburger Monosy | The Freiburger monosyllabic word test is performed 12 months after device activation |
|
|
the study is a retropective analysis of patients who were implanted between 2018-2023. Only performance date were analyzed. Serious and other [non-serious] adverse events were not collected or assessed as part of the study
Serious and other [non-serious] adverse events were not collected or assessed as part of the study
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EAS CI Users | adult EAS CI users implanted with an Ultra or Ultra 3D SlimJ implant between 2018 and 2023 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline-Marie Delattre | Advanced Bionics | +33788667472 | caroline-marie.delattre@advancedbionics.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2024 | Jan 29, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| duration of hearing impairment | Mean | Standard Deviation | years |
|
| duration of CI use | Mean | Standard Deviation | years |
|
| Participants |
|
|
| Secondary | Hochmair-Desoyer Schultz and Moser (HSM) Sentence Score or Oldenburger Sentence Test (OlSa) Recognition Score in Quiet | Percent correct in either the HSM sentence test or the Oldenburger sentence test (score from 0 to 100%) | Results of the sentence test are available for 17 subjects at 12m. Although 55 patients were included in this retrospective study, data at 12 months is not available for all the subjects. | Posted | Mean | Standard Deviation | percent correct in either the HSM senten | The test (HSM or OlSa) is performed 12 months after device activation |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |