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This is a prospective within-subjects repeated-measures study that will enroll 17 users 13 years or older implanted with a HiResolution Bionic Ear System.
The overall goal of this clinical study is to demonstrate the safety and efficacy of the remote fitting option. 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 described herein uses a non-inferiority design to determine whether sentence recognition in quiet is no worse with remote fitting than in an in-office setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electric Only | Other |
| |
| Aidable Residual Hearing | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Fitting | Device | Processors will be programmed using remote fitting application. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Speech Performance in Quiet After Chronic Use (EO Only) | The primary efficacy endpoint is the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post investigational remote fitting (visit 3) as compared to the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post control in-office fitting (visit 2). Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome. | 2-3 weeks after fitting |
| Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups) | The primary efficacy endpoint is the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post investigational remote fitting (visit 3) as compared to the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post control in-office fitting (visit 2). Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome. | Test performed 2-3 weeks after fitting |
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Inclusion Criteria All Subjects
Inclusion Criteria Specific to Aidable Residual Hearing Group
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
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Per protocol, a subject is considered enrolled upon giving written informed consent. After undergoing the ICF process, subjects completed a hearing test. Depending on the outcome of that test, eligible subjects were enrolled for aidable residual hearing (ARH) fitting with an acoustic earhook. Unilaterally implanted subjects not meeting ARH fitting criteria were enrolled for electric only (EO) fitting. Bilaterally implanted subjects meeting ARH criteria only in one ear were screen failed.
Investigators recruited study subjects from their clinical practices. The first patient visit occurred on 08/18/21 and last patient visit occurred on 05/23/22. Of the 19 enrolled, 2 were deemed ineligible to continue after visit 1 and 17 subjects were assigned to a study; 12 subjects were enrolled in the EO group and 5 subjects were enrolled in the ARH sub-group based on the results of their audiometric testing. All 17 subjects completed the study, with no withdrawals or losses to follow up.
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| ID | Title | Description |
|---|---|---|
| FG000 | Electric Only (EO) | Any subject that did not meet the ARH fitting criteria was enrolled in the EO fitting group. The EO group were fit with the investigational processor and an Advanced Bionics T-mic for the duration of the study. All subjects (both EO and ARH) underwent the same testing procedures after appropriately fitted. |
| FG001 | Aidable Residual Hearing (ARH) | A group of subjects that met the general study criteria and the inclusion criteria for ARH as follows:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Electric Only | Any subject that did not meet the ARH fitting criteria was enrolled in the EO fitting group. The EO group were fit with the investigational processor and an Advanced Bionics T-mic for the duration of the study. All subjects (both EO and ARH) underwent the same testing procedures after appropriately fitted. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Speech Performance in Quiet After Chronic Use (EO Only) | The primary efficacy endpoint is the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post investigational remote fitting (visit 3) as compared to the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post control in-office fitting (visit 2). Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome. | Posted | Mean | Standard Deviation | percentage of correctly recognized words | 2-3 weeks after fitting |
|
AEs were recorded and tracked between completion of the informed consent form and two weeks after the participant completes the study. This total time period is approximately 6-8 weeks dependent on the subject scheduled visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Electric Only | Remote Fitting: Processors will be programmed using remote fitting application. In-Office Fitting: Processors will be programmed using standard Target CI application. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Implant Failure - Right ear | Ear and labyrinth disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ankur Kaushal, VP of Global Regulatory Affairs | Advanced Bionics | 6613621400 | clinicalresearch@advancedbionics.com |
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| 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 | May 26, 2021 | Jul 28, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D004427 | Ear Diseases |
| D006311 | Hearing Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| In-Office Fitting | Device | Processors will be programmed using standard Target CI application. |
|
| Aidable Residual Hearing (ARH) |
Includes subjects that met all general inclusion criteria and hearing inclusion criteria specific for ARH group.
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | 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 |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups) | The primary efficacy endpoint is the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post investigational remote fitting (visit 3) as compared to the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post control in-office fitting (visit 2). Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome. | Posted | Mean | Standard Deviation | percentage of recognized words | Test performed 2-3 weeks after fitting |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 2 |
| 12 |
| EG001 | Aidable Residual Hearing | Remote Fitting: Processors will be programmed using remote fitting application. In-Office Fitting: Processors will be programmed using standard Target CI application. | 0 | 5 | 0 | 5 | 0 | 5 |
| Migraine Headache | General disorders | Non-systematic Assessment |
|
PI agrees to submit any publication to Sponsor at least 30 days before submission. Within 30 days, Sponsor advises PI in writing of any information contained therein which is Confidential Information (other than Study Data) or which may impair availability of patent protection for Inventions.
Sponsor has the right to require PI to remove specifically identified CI and/or to delay the publication for an additional 60 days to enable Sponsor to seek patent protection for Inventions.
| D013568 | Pathological Conditions, Signs and Symptoms |
|