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The study is a non-interventional, observational, cross-sectional, study on users of Ponto sound processors. The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with Oticon Medical's sound processors fitted with the Genie Medical fitting software.
The study is a non-interventional, observational, cross-sectional, study on users of Ponto sound processors. The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with Oticon Medical's sound processors fitted with the Genie Medical fitting software. Subjects fitted with one or two Ponto sound processors will be invited to participate in an online survey. The survey contains questions about the subjectively experienced performance and satisfaction of the device. The survey can be filled out on computer, tablet or mobile phone and should take the participants about 10 minutes to fill out.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ponto Users | Users that have been fitted with a Bone Anhcored Sound Processor, Ponto |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ponto Sound processor | Device | Bone Anchored Hearing solution fitted to compensate for the subjects hearing loss |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall IOI-HA Score | International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1) to best outcome (5). Evaluate subjectively assessed overall hearing performance and satisfaction with the Oticon Medical's Ponto sound processors. | at enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Factor 1 IOI-HA Score | Factor 1 International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1) to best outcome (5). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors | at enrollement |
| Factor 2 IOI-HA Score |
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Inclusion Criteria:
Online consent form filled out Has been fitted with at least one Ponto Sound Processor
Exclusion Criteria:
No exclusion criteria
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Users fitted with a Ponto sound processor
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Philipsson | Oticon Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oticon Medical | Somerset | New Jersey | 08873 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ponto Users | Users that have been fitted with a Bone Anhcored Sound Processor, Ponto Ponto Sound processor: Bone Anchored Hearing solution fitted to compensate for the subjects hearing loss |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ponto Users | Users that have been fitted with a Bone Anhcored Sound Processor, Ponto Ponto Sound processor: Bone Anchored Hearing solution fitted to compensate for the subjects hearing loss |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Overall IOI-HA Score | International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1) to best outcome (5). Evaluate subjectively assessed overall hearing performance and satisfaction with the Oticon Medical's Ponto sound processors. | Posted | Mean | Standard Deviation | score on a scale | at enrollment |
|
Collection of adverse events not applicable since study is a non-interventional, observational, cross-sectional, survey investigation
Collection of adverse events not applicable since study is a non-interventional, observational, cross-sectional, survey investigation
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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 | Ponto, Ponto Pro, & Ponto Plus | Type/model of Ponto sound processor | 0 |
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Survey study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nicole Amichetti | Oticon Medical | +1 609-366-0424 | nitc@oticonmedical.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 | Mar 15, 2022 | Mar 13, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006314 | Hearing Loss, Conductive |
| D046088 | Hearing Loss, Unilateral |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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Factor 2 International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1) to best outcome (5). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors |
| at enrollment |
| Per Item IOI-HA Score (Q1) | Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1) to best outcome (5). Here, this item queries average hours of use per day and a score of 1 is assigned for "none", a score of 2 assigned for "less than one hour per day", a score of 3 assigned for "1 to 4 hours per day", a score of 4 for "4 to 8 hours a day", and a score of 5 assigned for "more than 8 hours a day". Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors | at enrollment |
| Per Item IOI-HA Score (Q2) | Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: helped not at all) to best outcome (5: helped very much). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors | at enrollment |
| Per Item IOI-HA Score (Q3) | Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: Very much difficulty) to best outcome (5: No difficulty). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors | at enrollment |
| Per Item IOI-HA Score (Q4) | Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: Not worth it at all) to best outcome (5: Very much worth it). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors | at enrollment |
| Per Item IOI-HA Score (Q5) | Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: Affected very much) to best outcome (5: Affected not at all). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors | at enrollment |
| Per Item IOI-HA Score (Q6) | Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: bothered very much) to best outcome (5: Bothered not at all). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors | at enrollment |
| Per Item IOI-HA Score (Q7) | Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: Worse) to best outcome (5: Very much better). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors | at enrollment |
| Usage | Evaluate non-usage among patients fitted with a Ponto sound processor. Reported is number of participants by sound processor type. | at enrollment |
| Upgrade | Evaluate Ponto sound processor upgrade rate | enrollment |
| Participants |
|
| Sex/Gender, Customized | 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 |
|
| Current usage of device | Count of Participants | Participants |
|
| Uni- or bilateral use | Count of Participants | Participants |
|
| Softband or abutment fitting | Count of Participants | Participants |
|
Type/model of Ponto sound processor |
| OG003 | Ponto 4 | Type/model of Ponto sound processor |
| OG004 | Ponto 5 Mini | Type/model of Ponto sound processor |
| OG005 | Ponto 5 SuperPower | Type/model of Ponto sound processor |
|
|
| Secondary | Factor 1 IOI-HA Score | Factor 1 International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1) to best outcome (5). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors | Posted | Mean | Standard Deviation | score on a scale | at enrollement |
|
|
|
| Secondary | Factor 2 IOI-HA Score | Factor 2 International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1) to best outcome (5). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors | Posted | Mean | Standard Deviation | score on a scale | at enrollment |
|
|
|
| Secondary | Per Item IOI-HA Score (Q1) | Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1) to best outcome (5). Here, this item queries average hours of use per day and a score of 1 is assigned for "none", a score of 2 assigned for "less than one hour per day", a score of 3 assigned for "1 to 4 hours per day", a score of 4 for "4 to 8 hours a day", and a score of 5 assigned for "more than 8 hours a day". Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors | Posted | Count of Participants | Participants | at enrollment |
|
|
|
| Secondary | Per Item IOI-HA Score (Q2) | Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: helped not at all) to best outcome (5: helped very much). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors | Posted | Count of Participants | Participants | at enrollment |
|
|
|
| Secondary | Per Item IOI-HA Score (Q3) | Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: Very much difficulty) to best outcome (5: No difficulty). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors | Posted | Count of Participants | Participants | at enrollment |
|
|
|
| Secondary | Per Item IOI-HA Score (Q4) | Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: Not worth it at all) to best outcome (5: Very much worth it). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors | Posted | Count of Participants | Participants | at enrollment |
|
|
|
| Secondary | Per Item IOI-HA Score (Q5) | Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: Affected very much) to best outcome (5: Affected not at all). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors | Posted | Count of Participants | Participants | at enrollment |
|
|
|
| Secondary | Per Item IOI-HA Score (Q6) | Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: bothered very much) to best outcome (5: Bothered not at all). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors | Posted | Count of Participants | Participants | at enrollment |
|
|
|
| Secondary | Per Item IOI-HA Score (Q7) | Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: Worse) to best outcome (5: Very much better). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors | Posted | Count of Participants | Participants | at enrollment |
|
|
|
| Secondary | Usage | Evaluate non-usage among patients fitted with a Ponto sound processor. Reported is number of participants by sound processor type. | Posted | Count of Participants | Participants | at enrollment |
|
|
|
| Secondary | Upgrade | Evaluate Ponto sound processor upgrade rate | Posted | Count of Participants | Participants | enrollment |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Ponto 3 & Ponto 3 Power | Type/model of Ponto sound processor | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Ponto 3 SuperPower | Type/model of Ponto sound processor | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Ponto 4 | Type/model of Ponto sound processor | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Ponto 5 Mini | Type/model of Ponto sound processor | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Ponto 5 SuperPower | Type/model of Ponto sound processor | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Less than one hour a day |
|
| 1 to 4 hours a day |
|
| 4 to 8 hours a day |
|
| More than 8 hours a day |
|
| Helped slightly |
|
| Helped moderately |
|
| helped quite a lot |
|
| Helped very much |
|
| Quite a lot of difficulty |
|
| Moderate difficulty |
|
| Slight difficulty |
|
| No difficulty |
|
| Slightly worth it |
|
| Moderately worth it |
|
| Quite a lot of worth it |
|
| Very much worth it |
|
| Affected quite a lot |
|
| Affected moderately |
|
| Affected slightly |
|
| Affected not at all |
|
| Missing |
|
| Bothered quite a lot |
|
| Bothered moderately |
|
| Bothered slightly |
|
| Bothered not at all |
|
| No change |
|
| Slightly better |
|
| Quite a lot better |
|
| Very much better |
|
| No |
|
| Did not answer |
|