Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Unilateral
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPonto Sound processor
Bone Anchored Hearing solution fitted to compensate for the subjects hearing loss
Sponsors
Oticon Medical
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Online consent form filled out Has been fitted with at least one Ponto Sound Processor
Exclusion criteria
No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall IOI-HA Score | at enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upgrade | enrollment | Evaluate Ponto sound processor upgrade rate |
| Factor 1 IOI-HA Score | at enrollement | 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 |
| Factor 2 IOI-HA Score | at enrollment | 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 |
| Per Item IOI-HA Score (Q1) | at enrollment | 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 |
| Per Item IOI-HA Score (Q2) | at enrollment | 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 |
| Usage | at enrollment | Evaluate non-usage among patients fitted with a Ponto sound processor. Reported is number of participants by sound processor type. |
| Per Item IOI-HA Score (Q4) | at enrollment | 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 |
| Per Item IOI-HA Score (Q5) | at enrollment | 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 |
| Per Item IOI-HA Score (Q6) | at enrollment | 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 |
| Per Item IOI-HA Score (Q7) | at enrollment | 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 |
| Per Item IOI-HA Score (Q3) | at enrollment | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 170 |
| Total | 170 |
Baseline characteristics
| Characteristic | Ponto Users | — |
|---|---|---|
| Age, Customized Age of participants 18-65 years | 65 Participants | — |
| Age, Customized Age of participants <18 years | 6 Participants | — |
| Age, Customized Age of participants >65 years | 73 Participants | — |
| Age, Customized Age of participants Unknown | 26 Participants | — |
| Current usage of device | 163 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 170 participants | — |
| Sex/Gender, Customized Female | 93 Participants | — |
| Sex/Gender, Customized Male | 75 Participants | — |
| Sex/Gender, Customized Prefer not to answer | 1 Participants | — |
| Sex/Gender, Customized Unknown | 1 Participants | — |
| Softband or abutment fitting Abutment | 156 Participants | — |
| Softband or abutment fitting Softband | 3 Participants | — |
| Softband or abutment fitting Unknown | 11 Participants | — |
| Uni- or bilateral use Bilateral | 21 Participants | — |
| Uni- or bilateral use Unilateral | 138 Participants | — |
| Uni- or bilateral use Unknown | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: at enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ponto, Ponto Pro, & Ponto Plus | Overall IOI-HA Score | 3.98 score on a scale | Standard Deviation 0.12 |
| Ponto 3 & Ponto 3 Power | Overall IOI-HA Score | 3.96 score on a scale | Standard Deviation 0.12 |
| Ponto 3 SuperPower | Overall IOI-HA Score | 3.86 score on a scale | Standard Deviation 0.15 |
| Ponto 4 | Overall IOI-HA Score | 4.02 score on a scale | Standard Deviation 0.15 |
| Ponto 5 Mini | Overall IOI-HA Score | 4.22 score on a scale | Standard Deviation 0.21 |
| Ponto 5 SuperPower | Overall IOI-HA Score | 4.11 score on a scale | Standard Deviation 0.12 |
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
Time frame: at enrollement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ponto, Ponto Pro, & Ponto Plus | Factor 1 IOI-HA Score | 4.2 score on a scale | Standard Deviation 0.1 |
| Ponto 3 & Ponto 3 Power | Factor 1 IOI-HA Score | 4.2 score on a scale | Standard Deviation 0.1 |
| Ponto 3 SuperPower | Factor 1 IOI-HA Score | 4.1 score on a scale | Standard Deviation 0.1 |
| Ponto 4 | Factor 1 IOI-HA Score | 4.3 score on a scale | Standard Deviation 0.1 |
| Ponto 5 Mini | Factor 1 IOI-HA Score | 4.6 score on a scale | Standard Deviation 0.2 |
| Ponto 5 SuperPower | Factor 1 IOI-HA Score | 4.3 score on a scale | Standard Deviation 0.1 |
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
Time frame: at enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ponto, Ponto Pro, & Ponto Plus | Factor 2 IOI-HA Score | 3.7 score on a scale | Standard Deviation 0.1 |
| Ponto 3 & Ponto 3 Power | Factor 2 IOI-HA Score | 3.7 score on a scale | Standard Deviation 0.1 |
| Ponto 3 SuperPower | Factor 2 IOI-HA Score | 3.5 score on a scale | Standard Deviation 0.1 |
| Ponto 4 | Factor 2 IOI-HA Score | 3.7 score on a scale | Standard Deviation 0.2 |
| Ponto 5 Mini | Factor 2 IOI-HA Score | 3.8 score on a scale | Standard Deviation 0.2 |
| Ponto 5 SuperPower | Factor 2 IOI-HA Score | 3.7 score on a scale | Standard Deviation 0.1 |
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
Time frame: at enrollment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q1) | 4 to 8 hours a day | 7 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q1) | None | 1 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q1) | 1 to 4 hours a day | 2 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q1) | Less than one hour a day | 2 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q1) | More than 8 hours a day | 30 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q1) | More than 8 hours a day | 13 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q1) | 4 to 8 hours a day | 2 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q1) | None | 0 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q1) | 1 to 4 hours a day | 2 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q1) | Less than one hour a day | 3 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q1) | Less than one hour a day | 1 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q1) | More than 8 hours a day | 12 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q1) | None | 0 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q1) | 4 to 8 hours a day | 3 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q1) | 1 to 4 hours a day | 3 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q1) | 1 to 4 hours a day | 4 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q1) | None | 0 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q1) | Less than one hour a day | 1 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q1) | 4 to 8 hours a day | 6 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q1) | More than 8 hours a day | 31 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q1) | 4 to 8 hours a day | 1 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q1) | None | 0 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q1) | More than 8 hours a day | 8 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q1) | Less than one hour a day | 0 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q1) | 1 to 4 hours a day | 0 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q1) | None | 0 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q1) | 4 to 8 hours a day | 5 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q1) | Less than one hour a day | 1 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q1) | More than 8 hours a day | 13 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q1) | 1 to 4 hours a day | 2 Participants |
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
Time frame: at enrollment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q2) | helped quite a lot | 9 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q2) | Helped slightly | 3 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q2) | Helped not at all | 2 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q2) | Helped very much | 19 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q2) | Helped moderately | 9 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q2) | Helped slightly | 1 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q2) | helped quite a lot | 7 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q2) | Helped not at all | 0 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q2) | Helped very much | 8 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q2) | Helped moderately | 4 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q2) | Helped slightly | 0 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q2) | helped quite a lot | 4 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q2) | Helped very much | 8 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q2) | Helped moderately | 7 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q2) | Helped not at all | 0 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q2) | Helped moderately | 4 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q2) | Helped not at all | 0 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q2) | Helped slightly | 5 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q2) | helped quite a lot | 17 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q2) | Helped very much | 16 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q2) | helped quite a lot | 4 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q2) | Helped not at all | 0 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q2) | Helped very much | 4 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q2) | Helped slightly | 0 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q2) | Helped moderately | 1 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q2) | Helped not at all | 0 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q2) | helped quite a lot | 6 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q2) | Helped slightly | 1 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q2) | Helped very much | 10 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q2) | Helped moderately | 4 Participants |
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
Time frame: at enrollment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q3) | Quite a lot of difficulty | 3 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q3) | Moderate difficulty | 12 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q3) | Very much difficulty | 1 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q3) | Slight difficulty | 22 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q3) | No difficulty | 4 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q3) | No difficulty | 2 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q3) | Very much difficulty | 1 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q3) | Quite a lot of difficulty | 3 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q3) | Moderate difficulty | 4 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q3) | Slight difficulty | 10 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q3) | Quite a lot of difficulty | 1 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q3) | Slight difficulty | 3 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q3) | No difficulty | 3 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q3) | Very much difficulty | 1 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q3) | Moderate difficulty | 11 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q3) | No difficulty | 2 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q3) | Quite a lot of difficulty | 1 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q3) | Moderate difficulty | 15 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q3) | Slight difficulty | 21 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q3) | Very much difficulty | 3 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q3) | Moderate difficulty | 0 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q3) | Quite a lot of difficulty | 3 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q3) | Very much difficulty | 0 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q3) | No difficulty | 1 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q3) | Slight difficulty | 5 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q3) | No difficulty | 4 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q3) | Very much difficulty | 1 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q3) | Moderate difficulty | 3 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q3) | Slight difficulty | 11 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q3) | Quite a lot of difficulty | 2 Participants |
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
Time frame: at enrollment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q4) | Quite a lot of worth it | 7 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q4) | Slightly worth it | 3 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q4) | Not at all worth it | 1 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q4) | Very much worth it | 25 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q4) | Moderately worth it | 6 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q4) | Slightly worth it | 0 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q4) | Quite a lot of worth it | 5 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q4) | Not at all worth it | 1 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q4) | Very much worth it | 12 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q4) | Moderately worth it | 2 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q4) | Slightly worth it | 0 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q4) | Quite a lot of worth it | 4 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q4) | Very much worth it | 10 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q4) | Moderately worth it | 5 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q4) | Not at all worth it | 0 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q4) | Moderately worth it | 5 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q4) | Not at all worth it | 0 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q4) | Slightly worth it | 4 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q4) | Quite a lot of worth it | 7 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q4) | Very much worth it | 26 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q4) | Quite a lot of worth it | 2 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q4) | Not at all worth it | 0 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q4) | Very much worth it | 7 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q4) | Slightly worth it | 0 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q4) | Moderately worth it | 0 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q4) | Not at all worth it | 0 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q4) | Quite a lot of worth it | 3 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q4) | Slightly worth it | 1 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q4) | Very much worth it | 14 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q4) | Moderately worth it | 3 Participants |
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
Time frame: at enrollment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q5) | Affected moderately | 7 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q5) | Affected not at all | 8 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q5) | Affected very much | 2 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q5) | Missing | 1 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q5) | Affected quite a lot | 4 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q5) | Affected slightly | 20 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q5) | Affected slightly | 7 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q5) | Affected moderately | 7 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q5) | Missing | 0 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q5) | Affected quite a lot | 2 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q5) | Affected not at all | 4 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q5) | Affected very much | 0 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q5) | Affected not at all | 4 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q5) | Affected very much | 1 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q5) | Missing | 0 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q5) | Affected slightly | 7 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q5) | Affected moderately | 4 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q5) | Affected quite a lot | 3 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q5) | Affected slightly | 20 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q5) | Affected very much | 3 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q5) | Affected quite a lot | 4 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q5) | Affected moderately | 7 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q5) | Affected not at all | 8 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q5) | Missing | 0 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q5) | Affected very much | 0 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q5) | Missing | 0 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q5) | Affected slightly | 4 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q5) | Affected not at all | 1 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q5) | Affected moderately | 3 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q5) | Affected quite a lot | 1 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q5) | Affected moderately | 4 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q5) | Affected very much | 2 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q5) | Affected not at all | 4 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q5) | Affected slightly | 9 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q5) | Missing | 1 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q5) | Affected quite a lot | 1 Participants |
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
Time frame: at enrollment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q6) | Bothered slightly | 11 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q6) | Bothered quite a lot | 5 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q6) | Bothered very much | 1 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q6) | Bothered not at all | 16 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q6) | Bothered moderately | 9 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q6) | Bothered quite a lot | 1 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q6) | Bothered slightly | 8 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q6) | Bothered very much | 0 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q6) | Bothered not at all | 5 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q6) | Bothered moderately | 6 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q6) | Bothered quite a lot | 2 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q6) | Bothered slightly | 9 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q6) | Bothered not at all | 5 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q6) | Bothered moderately | 1 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q6) | Bothered very much | 2 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q6) | Bothered moderately | 6 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q6) | Bothered very much | 1 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q6) | Bothered quite a lot | 4 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q6) | Bothered slightly | 16 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q6) | Bothered not at all | 15 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q6) | Bothered slightly | 1 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q6) | Bothered very much | 0 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q6) | Bothered not at all | 5 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q6) | Bothered quite a lot | 0 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q6) | Bothered moderately | 3 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q6) | Bothered very much | 0 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q6) | Bothered slightly | 4 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q6) | Bothered quite a lot | 2 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q6) | Bothered not at all | 11 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q6) | Bothered moderately | 4 Participants |
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
Time frame: at enrollment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q7) | Slightly better | 7 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q7) | Quite a lot better | 14 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q7) | Worse | 0 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q7) | No change | 4 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Per Item IOI-HA Score (Q7) | Very much better | 17 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q7) | Worse | 1 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q7) | Quite a lot better | 8 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q7) | Slightly better | 2 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q7) | No change | 1 Participants |
| Ponto 3 & Ponto 3 Power | Per Item IOI-HA Score (Q7) | Very much better | 8 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q7) | Quite a lot better | 6 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q7) | No change | 2 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q7) | Slightly better | 5 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q7) | Worse | 0 Participants |
| Ponto 3 SuperPower | Per Item IOI-HA Score (Q7) | Very much better | 6 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q7) | Slightly better | 8 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q7) | Worse | 0 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q7) | No change | 3 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q7) | Quite a lot better | 10 Participants |
| Ponto 4 | Per Item IOI-HA Score (Q7) | Very much better | 21 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q7) | Quite a lot better | 2 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q7) | Worse | 0 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q7) | Very much better | 5 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q7) | No change | 0 Participants |
| Ponto 5 Mini | Per Item IOI-HA Score (Q7) | Slightly better | 2 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q7) | Worse | 0 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q7) | Quite a lot better | 5 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q7) | No change | 1 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q7) | Very much better | 11 Participants |
| Ponto 5 SuperPower | Per Item IOI-HA Score (Q7) | Slightly better | 4 Participants |
Secondary
Upgrade
Evaluate Ponto sound processor upgrade rate
Time frame: enrollment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ponto, Ponto Pro, & Ponto Plus | Upgrade | Did not answer | 1 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Upgrade | Yes | 16 Participants |
| Ponto, Ponto Pro, & Ponto Plus | Upgrade | No | 25 Participants |
| Ponto 3 & Ponto 3 Power | Upgrade | No | 9 Participants |
| Ponto 3 & Ponto 3 Power | Upgrade | Yes | 11 Participants |
| Ponto 3 & Ponto 3 Power | Upgrade | Did not answer | 0 Participants |
| Ponto 3 SuperPower | Upgrade | Yes | 12 Participants |
| Ponto 3 SuperPower | Upgrade | Did not answer | 0 Participants |
| Ponto 3 SuperPower | Upgrade | No | 7 Participants |
| Ponto 4 | Upgrade | No | 19 Participants |
| Ponto 4 | Upgrade | Did not answer | 0 Participants |
| Ponto 4 | Upgrade | Yes | 23 Participants |
| Ponto 5 Mini | Upgrade | No | 4 Participants |
| Ponto 5 Mini | Upgrade | Yes | 5 Participants |
| Ponto 5 Mini | Upgrade | Did not answer | 0 Participants |
| Ponto 5 SuperPower | Upgrade | No | 9 Participants |
| Ponto 5 SuperPower | Upgrade | Did not answer | 0 Participants |
| Ponto 5 SuperPower | Upgrade | Yes | 12 Participants |
Secondary
Usage
Evaluate non-usage among patients fitted with a Ponto sound processor. Reported is number of participants by sound processor type.
Time frame: at enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ponto, Ponto Pro, & Ponto Plus | Usage | 0 Participants |
| Ponto 3 & Ponto 3 Power | Usage | 0 Participants |
| Ponto 3 SuperPower | Usage | 0 Participants |
| Ponto 4 | Usage | 0 Participants |
| Ponto 5 Mini | Usage | 0 Participants |
| Ponto 5 SuperPower | Usage | 0 Participants |