Trial Outcomes & Findings for Cross-sectional Evaluation of the Subjective Performance and Satisfaction With Ponto Sound Processors (NCT NCT05356221)
NCT ID: NCT05356221
Last Updated: 2025-08-17
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
170 participants
Primary outcome timeframe
at enrollment
Results posted on
2025-08-17
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
170
|
|
Overall Study
COMPLETED
|
153
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ponto Users
n=170 Participants
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
|
|---|---|
|
Age, Customized
Age of participants · <18 years
|
6 Participants
n=170 Participants
|
|
Age, Customized
Age of participants · 18-65 years
|
65 Participants
n=170 Participants
|
|
Age, Customized
Age of participants · >65 years
|
73 Participants
n=170 Participants
|
|
Age, Customized
Age of participants · Unknown
|
26 Participants
n=170 Participants
|
|
Sex/Gender, Customized
Male
|
75 Participants
n=170 Participants
|
|
Sex/Gender, Customized
Female
|
93 Participants
n=170 Participants
|
|
Sex/Gender, Customized
Prefer not to answer
|
1 Participants
n=170 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 Participants
n=170 Participants
|
|
Region of Enrollment
United States
|
170 participants
n=170 Participants
|
|
Current usage of device
|
163 Participants
n=170 Participants
|
|
Uni- or bilateral use
Unilateral
|
138 Participants
n=170 Participants
|
|
Uni- or bilateral use
Bilateral
|
21 Participants
n=170 Participants
|
|
Uni- or bilateral use
Unknown
|
11 Participants
n=170 Participants
|
|
Softband or abutment fitting
Softband
|
3 Participants
n=170 Participants
|
|
Softband or abutment fitting
Abutment
|
156 Participants
n=170 Participants
|
|
Softband or abutment fitting
Unknown
|
11 Participants
n=170 Participants
|
PRIMARY outcome
Timeframe: at enrollmentInternational 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.
Outcome measures
| Measure |
Ponto, Ponto Pro, & Ponto Plus
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 3 & Ponto 3 Power
n=20 Participants
Type/model of Ponto sound processor
|
Ponto 3 SuperPower
n=19 Participants
Type/model of Ponto sound processor
|
Ponto 4
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 5 Mini
n=9 Participants
Type/model of Ponto sound processor
|
Ponto 5 SuperPower
n=21 Participants
Type/model of Ponto sound processor
|
|---|---|---|---|---|---|---|
|
Overall IOI-HA Score
|
3.98 score on a scale
Standard Deviation 0.12
|
3.96 score on a scale
Standard Deviation 0.12
|
3.86 score on a scale
Standard Deviation 0.15
|
4.02 score on a scale
Standard Deviation 0.15
|
4.22 score on a scale
Standard Deviation 0.21
|
4.11 score on a scale
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: at enrollementFactor 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
Outcome measures
| Measure |
Ponto, Ponto Pro, & Ponto Plus
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 3 & Ponto 3 Power
n=20 Participants
Type/model of Ponto sound processor
|
Ponto 3 SuperPower
n=19 Participants
Type/model of Ponto sound processor
|
Ponto 4
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 5 Mini
n=9 Participants
Type/model of Ponto sound processor
|
Ponto 5 SuperPower
n=21 Participants
Type/model of Ponto sound processor
|
|---|---|---|---|---|---|---|
|
Factor 1 IOI-HA Score
|
4.2 score on a scale
Standard Deviation 0.1
|
4.2 score on a scale
Standard Deviation 0.1
|
4.1 score on a scale
Standard Deviation 0.1
|
4.3 score on a scale
Standard Deviation 0.1
|
4.6 score on a scale
Standard Deviation 0.2
|
4.3 score on a scale
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: at enrollmentFactor 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
Outcome measures
| Measure |
Ponto, Ponto Pro, & Ponto Plus
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 3 & Ponto 3 Power
n=20 Participants
Type/model of Ponto sound processor
|
Ponto 3 SuperPower
n=19 Participants
Type/model of Ponto sound processor
|
Ponto 4
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 5 Mini
n=9 Participants
Type/model of Ponto sound processor
|
Ponto 5 SuperPower
n=21 Participants
Type/model of Ponto sound processor
|
|---|---|---|---|---|---|---|
|
Factor 2 IOI-HA Score
|
3.7 score on a scale
Standard Deviation 0.1
|
3.7 score on a scale
Standard Deviation 0.1
|
3.5 score on a scale
Standard Deviation 0.1
|
3.7 score on a scale
Standard Deviation 0.2
|
3.8 score on a scale
Standard Deviation 0.2
|
3.7 score on a scale
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: at enrollmentPer 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
Outcome measures
| Measure |
Ponto, Ponto Pro, & Ponto Plus
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 3 & Ponto 3 Power
n=20 Participants
Type/model of Ponto sound processor
|
Ponto 3 SuperPower
n=19 Participants
Type/model of Ponto sound processor
|
Ponto 4
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 5 Mini
n=9 Participants
Type/model of Ponto sound processor
|
Ponto 5 SuperPower
n=21 Participants
Type/model of Ponto sound processor
|
|---|---|---|---|---|---|---|
|
Per Item IOI-HA Score (Q1)
None
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Per Item IOI-HA Score (Q1)
Less than one hour a day
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Per Item IOI-HA Score (Q1)
1 to 4 hours a day
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
|
Per Item IOI-HA Score (Q1)
4 to 8 hours a day
|
7 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
5 Participants
|
|
Per Item IOI-HA Score (Q1)
More than 8 hours a day
|
30 Participants
|
13 Participants
|
12 Participants
|
31 Participants
|
8 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: at enrollmentPer 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
Outcome measures
| Measure |
Ponto, Ponto Pro, & Ponto Plus
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 3 & Ponto 3 Power
n=20 Participants
Type/model of Ponto sound processor
|
Ponto 3 SuperPower
n=19 Participants
Type/model of Ponto sound processor
|
Ponto 4
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 5 Mini
n=9 Participants
Type/model of Ponto sound processor
|
Ponto 5 SuperPower
n=21 Participants
Type/model of Ponto sound processor
|
|---|---|---|---|---|---|---|
|
Per Item IOI-HA Score (Q2)
Helped not at all
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Per Item IOI-HA Score (Q2)
Helped slightly
|
3 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Per Item IOI-HA Score (Q2)
Helped moderately
|
9 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Per Item IOI-HA Score (Q2)
helped quite a lot
|
9 Participants
|
7 Participants
|
4 Participants
|
17 Participants
|
4 Participants
|
6 Participants
|
|
Per Item IOI-HA Score (Q2)
Helped very much
|
19 Participants
|
8 Participants
|
8 Participants
|
16 Participants
|
4 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: at enrollmentPer 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
Outcome measures
| Measure |
Ponto, Ponto Pro, & Ponto Plus
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 3 & Ponto 3 Power
n=20 Participants
Type/model of Ponto sound processor
|
Ponto 3 SuperPower
n=19 Participants
Type/model of Ponto sound processor
|
Ponto 4
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 5 Mini
n=9 Participants
Type/model of Ponto sound processor
|
Ponto 5 SuperPower
n=21 Participants
Type/model of Ponto sound processor
|
|---|---|---|---|---|---|---|
|
Per Item IOI-HA Score (Q3)
Very much difficulty
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Per Item IOI-HA Score (Q3)
Quite a lot of difficulty
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Per Item IOI-HA Score (Q3)
Moderate difficulty
|
12 Participants
|
4 Participants
|
11 Participants
|
15 Participants
|
0 Participants
|
3 Participants
|
|
Per Item IOI-HA Score (Q3)
Slight difficulty
|
22 Participants
|
10 Participants
|
3 Participants
|
21 Participants
|
5 Participants
|
11 Participants
|
|
Per Item IOI-HA Score (Q3)
No difficulty
|
4 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: at enrollmentPer 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
Outcome measures
| Measure |
Ponto, Ponto Pro, & Ponto Plus
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 3 & Ponto 3 Power
n=20 Participants
Type/model of Ponto sound processor
|
Ponto 3 SuperPower
n=19 Participants
Type/model of Ponto sound processor
|
Ponto 4
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 5 Mini
n=9 Participants
Type/model of Ponto sound processor
|
Ponto 5 SuperPower
n=21 Participants
Type/model of Ponto sound processor
|
|---|---|---|---|---|---|---|
|
Per Item IOI-HA Score (Q4)
Not at all worth it
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Per Item IOI-HA Score (Q4)
Slightly worth it
|
3 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Per Item IOI-HA Score (Q4)
Moderately worth it
|
6 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
|
Per Item IOI-HA Score (Q4)
Quite a lot of worth it
|
7 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
3 Participants
|
|
Per Item IOI-HA Score (Q4)
Very much worth it
|
25 Participants
|
12 Participants
|
10 Participants
|
26 Participants
|
7 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: at enrollmentPer 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
Outcome measures
| Measure |
Ponto, Ponto Pro, & Ponto Plus
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 3 & Ponto 3 Power
n=20 Participants
Type/model of Ponto sound processor
|
Ponto 3 SuperPower
n=19 Participants
Type/model of Ponto sound processor
|
Ponto 4
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 5 Mini
n=9 Participants
Type/model of Ponto sound processor
|
Ponto 5 SuperPower
n=21 Participants
Type/model of Ponto sound processor
|
|---|---|---|---|---|---|---|
|
Per Item IOI-HA Score (Q5)
Affected very much
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Per Item IOI-HA Score (Q5)
Affected quite a lot
|
4 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Per Item IOI-HA Score (Q5)
Affected moderately
|
7 Participants
|
7 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
|
Per Item IOI-HA Score (Q5)
Affected slightly
|
20 Participants
|
7 Participants
|
7 Participants
|
20 Participants
|
4 Participants
|
9 Participants
|
|
Per Item IOI-HA Score (Q5)
Affected not at all
|
8 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
1 Participants
|
4 Participants
|
|
Per Item IOI-HA Score (Q5)
Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: at enrollmentPer 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
Outcome measures
| Measure |
Ponto, Ponto Pro, & Ponto Plus
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 3 & Ponto 3 Power
n=20 Participants
Type/model of Ponto sound processor
|
Ponto 3 SuperPower
n=19 Participants
Type/model of Ponto sound processor
|
Ponto 4
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 5 Mini
n=9 Participants
Type/model of Ponto sound processor
|
Ponto 5 SuperPower
n=21 Participants
Type/model of Ponto sound processor
|
|---|---|---|---|---|---|---|
|
Per Item IOI-HA Score (Q6)
Bothered very much
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Per Item IOI-HA Score (Q6)
Bothered quite a lot
|
5 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
|
Per Item IOI-HA Score (Q6)
Bothered moderately
|
9 Participants
|
6 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
|
Per Item IOI-HA Score (Q6)
Bothered slightly
|
11 Participants
|
8 Participants
|
9 Participants
|
16 Participants
|
1 Participants
|
4 Participants
|
|
Per Item IOI-HA Score (Q6)
Bothered not at all
|
16 Participants
|
5 Participants
|
5 Participants
|
15 Participants
|
5 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: at enrollmentPer 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
Outcome measures
| Measure |
Ponto, Ponto Pro, & Ponto Plus
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 3 & Ponto 3 Power
n=20 Participants
Type/model of Ponto sound processor
|
Ponto 3 SuperPower
n=19 Participants
Type/model of Ponto sound processor
|
Ponto 4
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 5 Mini
n=9 Participants
Type/model of Ponto sound processor
|
Ponto 5 SuperPower
n=21 Participants
Type/model of Ponto sound processor
|
|---|---|---|---|---|---|---|
|
Per Item IOI-HA Score (Q7)
Very much better
|
17 Participants
|
8 Participants
|
6 Participants
|
21 Participants
|
5 Participants
|
11 Participants
|
|
Per Item IOI-HA Score (Q7)
Worse
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Per Item IOI-HA Score (Q7)
No change
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Per Item IOI-HA Score (Q7)
Slightly better
|
7 Participants
|
2 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
4 Participants
|
|
Per Item IOI-HA Score (Q7)
Quite a lot better
|
14 Participants
|
8 Participants
|
6 Participants
|
10 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: at enrollmentEvaluate non-usage among patients fitted with a Ponto sound processor. Reported is number of participants by sound processor type.
Outcome measures
| Measure |
Ponto, Ponto Pro, & Ponto Plus
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 3 & Ponto 3 Power
n=20 Participants
Type/model of Ponto sound processor
|
Ponto 3 SuperPower
n=19 Participants
Type/model of Ponto sound processor
|
Ponto 4
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 5 Mini
n=9 Participants
Type/model of Ponto sound processor
|
Ponto 5 SuperPower
n=21 Participants
Type/model of Ponto sound processor
|
|---|---|---|---|---|---|---|
|
Usage
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: enrollmentEvaluate Ponto sound processor upgrade rate
Outcome measures
| Measure |
Ponto, Ponto Pro, & Ponto Plus
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 3 & Ponto 3 Power
n=20 Participants
Type/model of Ponto sound processor
|
Ponto 3 SuperPower
n=19 Participants
Type/model of Ponto sound processor
|
Ponto 4
n=42 Participants
Type/model of Ponto sound processor
|
Ponto 5 Mini
n=9 Participants
Type/model of Ponto sound processor
|
Ponto 5 SuperPower
n=21 Participants
Type/model of Ponto sound processor
|
|---|---|---|---|---|---|---|
|
Upgrade
Yes
|
16 Participants
|
11 Participants
|
12 Participants
|
23 Participants
|
5 Participants
|
12 Participants
|
|
Upgrade
No
|
25 Participants
|
9 Participants
|
7 Participants
|
19 Participants
|
4 Participants
|
9 Participants
|
|
Upgrade
Did not answer
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Ponto, Ponto Pro, & Ponto Plus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ponto 3 & Ponto 3 Power
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ponto 3 SuperPower
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ponto 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ponto 5 Mini
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ponto 5 SuperPower
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place