Trial Outcomes & Findings for Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear (NCT NCT04803279)
NCT ID: NCT04803279
Last Updated: 2025-08-26
Results Overview
Functional gain is the difference between the average unaided threshold measured across the frequencies of 500, 1000, 2000 and 4000 Hz and the average aided (i.e. with the Ponto 3 SuperPower) threshold measured across the frequencies of 500, 1000, 2000 and 4000 Hz. For bilaterally fitted patients, the best ear is selected.
COMPLETED
57 participants
Visit 2, 3 months
2025-08-26
Participant Flow
Target population 1 - Conductive/Mixed Hearing Loss (CHL/MHL) within indication Target population 1 - Bilaterally fitted CHL/MHL within indication Target population 2 - Single Sided Deafness (SSD) within indication Participants were assigned into groups based on type of hearing loss (not by ears or any other unit).
Participant milestones
| Measure |
Target Population 1 - CHL/MHL
CHL/MHL within indication
|
Target Population 2 - CHL/MHL Bilateral
Bilateral CHL/MHL within indication
|
Target Population 3 - SSD
SSD within indication (TP3 - SSD)
|
|---|---|---|---|
|
Overall Study
STARTED
|
46
|
8
|
3
|
|
Overall Study
COMPLETED
|
46
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Target Population 1 - CHL/MHL
n=46 Participants
TP 1 - Conductive Hearing Loss (CHL) / Mixed Hearing Loss (MHL) within indication.
|
Target Population 2 - Bilateral
n=8 Participants
TP 2- Patients with CHL/MHL who were bilaterally fitted.
|
Target Population 3 - SSD
n=3 Participants
TP 3 - Single Sided Deafness (SSD) within indication
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 16.4 • n=46 Participants
|
63.5 years
STANDARD_DEVIATION 15.6 • n=8 Participants
|
57.7 years
STANDARD_DEVIATION 4.7 • n=3 Participants
|
60.6 years
STANDARD_DEVIATION 15.6 • n=57 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=46 Participants
|
7 Participants
n=8 Participants
|
1 Participants
n=3 Participants
|
38 Participants
n=57 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=46 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=3 Participants
|
19 Participants
n=57 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Visit 2, 3 monthsPopulation: Measurement not applicable for Target Population 3 - SSD
Functional gain is the difference between the average unaided threshold measured across the frequencies of 500, 1000, 2000 and 4000 Hz and the average aided (i.e. with the Ponto 3 SuperPower) threshold measured across the frequencies of 500, 1000, 2000 and 4000 Hz. For bilaterally fitted patients, the best ear is selected.
Outcome measures
| Measure |
Target Population 1 - CHL/MHL
n=46 Participants
TP 1 - Conductive Hearing Loss (CHL) / Mixed Hearing Loss (MHL) within indication.
|
Target Population 2 - Bilateral
n=8 Participants
TP 2 Patients with CHL/MHL who were bilaterally fitted.
|
Target Population 3 - SSD
TP3 - Single Sided Deafness (SSD) within indication
|
|---|---|---|---|
|
Change in Functional Gain Thresholds: Unaided Air Conduction (AC) Thresholds Compared to Aided Bone Conduction (BC) Thresholds, in Ponto 3 SuperPower Users With Conductive Hearing Loss (CHL) and/or Mixed Hearing Loss (MHL).
Unaided AC [dB]
|
70.2 dB
Standard Deviation 17.9
|
64.2 dB
Standard Deviation 19.4
|
—
|
|
Change in Functional Gain Thresholds: Unaided Air Conduction (AC) Thresholds Compared to Aided Bone Conduction (BC) Thresholds, in Ponto 3 SuperPower Users With Conductive Hearing Loss (CHL) and/or Mixed Hearing Loss (MHL).
Aided sound field [dB]
|
35.6 dB
Standard Deviation 9.0
|
35.2 dB
Standard Deviation 4.2
|
—
|
|
Change in Functional Gain Thresholds: Unaided Air Conduction (AC) Thresholds Compared to Aided Bone Conduction (BC) Thresholds, in Ponto 3 SuperPower Users With Conductive Hearing Loss (CHL) and/or Mixed Hearing Loss (MHL).
Functional gain Unaided (AC) - Aided [dB]
|
36.0 dB
Standard Deviation 13.9
|
31.9 dB
Standard Deviation 15.4
|
—
|
SECONDARY outcome
Timeframe: Visit 1, Day 1Population: This variable is specific for patients with CHL/MHL only and thus not applicable for those with single-sided deafness, i.e., Target Population 3 - SSD.
Functional gain with Ponto 3 SuperPower, i.e. the difference between average unaided AC thresholds and aided sound field thresholds for frequencies 500, 1000, 2000, 3000 and 4000 Hz. For bilaterally fitted patients, the best ear is selected.
Outcome measures
| Measure |
Target Population 1 - CHL/MHL
n=46 Participants
TP 1 - Conductive Hearing Loss (CHL) / Mixed Hearing Loss (MHL) within indication.
|
Target Population 2 - Bilateral
n=8 Participants
TP 2 Patients with CHL/MHL who were bilaterally fitted.
|
Target Population 3 - SSD
TP3 - Single Sided Deafness (SSD) within indication
|
|---|---|---|---|
|
Functional Gain With the Ponto 3 SuperPower for Patients With CHL/MHL.
500 Hz
|
38.3 Functional gain Unaided (AC) - Aided [dB
Standard Deviation 17.6
|
35.0 Functional gain Unaided (AC) - Aided [dB
Standard Deviation 12.9
|
—
|
|
Functional Gain With the Ponto 3 SuperPower for Patients With CHL/MHL.
1000 Hz
|
37.4 Functional gain Unaided (AC) - Aided [dB
Standard Deviation 15.8
|
35.7 Functional gain Unaided (AC) - Aided [dB
Standard Deviation 15.7
|
—
|
|
Functional Gain With the Ponto 3 SuperPower for Patients With CHL/MHL.
2000 Hz
|
31.7 Functional gain Unaided (AC) - Aided [dB
Standard Deviation 17.1
|
26.4 Functional gain Unaided (AC) - Aided [dB
Standard Deviation 16.8
|
—
|
|
Functional Gain With the Ponto 3 SuperPower for Patients With CHL/MHL.
3000 Hz
|
34.2 Functional gain Unaided (AC) - Aided [dB
Standard Deviation 18.2
|
32.1 Functional gain Unaided (AC) - Aided [dB
Standard Deviation 24.5
|
—
|
|
Functional Gain With the Ponto 3 SuperPower for Patients With CHL/MHL.
4000 Hz
|
37.0 Functional gain Unaided (AC) - Aided [dB
Standard Deviation 16.5
|
35.0 Functional gain Unaided (AC) - Aided [dB
Standard Deviation 21.2
|
—
|
SECONDARY outcome
Timeframe: Visit 2, 3 monthsPopulation: Participants with speech recognition scores recorded included in analysis speech recognition scores. This variable is specific for patients with CHL/MHL only and thus not applicable for those with single-sided deafness, i.e., Target Population 3 - SSD.
Aided speech recognition (% correct words) measured in quiet and in noise with the BKB sentence test and the AB\[s\] short list test averaged across patients. Only participants with data for both visits were included in analysis.
Outcome measures
| Measure |
Target Population 1 - CHL/MHL
n=46 Participants
TP 1 - Conductive Hearing Loss (CHL) / Mixed Hearing Loss (MHL) within indication.
|
Target Population 2 - Bilateral
n=8 Participants
TP 2 Patients with CHL/MHL who were bilaterally fitted.
|
Target Population 3 - SSD
TP3 - Single Sided Deafness (SSD) within indication
|
|---|---|---|---|
|
Improvement of Speech Recognition in Quiet and in Noise With Ponto 3 SuperPower for Patients With CHL/MHL
BKB Sentence Test in Noise
|
73.5 percent correct words
Standard Deviation 19.0
|
66.5 percent correct words
Standard Deviation 23.8
|
—
|
|
Improvement of Speech Recognition in Quiet and in Noise With Ponto 3 SuperPower for Patients With CHL/MHL
BKB Sentence Test in Quiet
|
88.6 percent correct words
Standard Deviation 11.3
|
91.5 percent correct words
Standard Deviation 7.1
|
—
|
|
Improvement of Speech Recognition in Quiet and in Noise With Ponto 3 SuperPower for Patients With CHL/MHL
AB[s] short list in Noise
|
67.6 percent correct words
Standard Deviation 21.0
|
59.0 percent correct words
Standard Deviation 21.8
|
—
|
|
Improvement of Speech Recognition in Quiet and in Noise With Ponto 3 SuperPower for Patients With CHL/MHL
AB[s] short list in Quiet
|
84.1 percent correct words
Standard Deviation 18.7
|
87.7 percent correct words
Standard Deviation 9.3
|
—
|
SECONDARY outcome
Timeframe: Visit 2, 3 monthsPopulation: The aided condition was obtained from two patients while the unaided condition was measured for one patient from the SSD patients within indication (TP2 - SSD, n=3). This outcome is only applicable for Target Population 3 - SSD.
Difference in speech recognition score (%) for speech recognition in noise between unaided and aided when speech is directed to the aided ear, and noise is directed to the non-implanted ear, and when speech is directed to the non-implanted ear, and when noise is directed to the aided ear. Aided and unaided speech recognition (% correct words) measured with the AB\[s\] short list.
Outcome measures
| Measure |
Target Population 1 - CHL/MHL
TP 1 - Conductive Hearing Loss (CHL) / Mixed Hearing Loss (MHL) within indication.
|
Target Population 2 - Bilateral
TP 2 Patients with CHL/MHL who were bilaterally fitted.
|
Target Population 3 - SSD
n=3 Participants
TP3 - Single Sided Deafness (SSD) within indication
|
|---|---|---|---|
|
Speech Recognition in Noise Improvements With Ponto 3 SuperPower on for Patients With SSD
Aided SimplatedNnon-implanted - % correct
|
—
|
—
|
60.0 percent correct words
Standard Deviation 9.5
|
|
Speech Recognition in Noise Improvements With Ponto 3 SuperPower on for Patients With SSD
Unaided SimplatedNnon-implanted - % correct
|
—
|
—
|
36.7 percent correct words
Standard Deviation 0
|
|
Speech Recognition in Noise Improvements With Ponto 3 SuperPower on for Patients With SSD
Difference: Aided - Unaided SimplatedNnon-implanted - % correct
|
—
|
—
|
30.0 percent correct words
Standard Deviation 0
|
|
Speech Recognition in Noise Improvements With Ponto 3 SuperPower on for Patients With SSD
Aided Snon-implatedNimplanted - % correct
|
—
|
—
|
80.0 percent correct words
Standard Deviation 23.6
|
|
Speech Recognition in Noise Improvements With Ponto 3 SuperPower on for Patients With SSD
Unaided Snon-implatedNimplanted - % correct
|
—
|
—
|
91.3 percent correct words
Standard Deviation 0
|
|
Speech Recognition in Noise Improvements With Ponto 3 SuperPower on for Patients With SSD
Difference: Aided- Unaided Snon-implatedNimplanted - % correct
|
—
|
—
|
5.40 percent correct words
Standard Deviation 0
|
SECONDARY outcome
Timeframe: visit 2, 3 monthsPopulation: Analysis includes tested frequencies. This variable is specific for patients with CHL/MHL only and thus not applicable for those with single-sided deafness, i.e., Target Population 3 - SSD.
Effective gain with Ponto 3 SuperPower, i.e. the difference between aided sound field thresholds and the BC In-situ thresholds on the aided ear(s) measured when the Ponto 3 SuperPower(s) was fitted. The effective gain is calculated as the average (PTA4) of frequencies 500, 1000, 2000 and 4000 Hz. Only participants with data for both study visits were included in the analysis.
Outcome measures
| Measure |
Target Population 1 - CHL/MHL
n=46 Participants
TP 1 - Conductive Hearing Loss (CHL) / Mixed Hearing Loss (MHL) within indication.
|
Target Population 2 - Bilateral
n=8 Participants
TP 2 Patients with CHL/MHL who were bilaterally fitted.
|
Target Population 3 - SSD
TP3 - Single Sided Deafness (SSD) within indication
|
|---|---|---|---|
|
Degree of Compensation for Hearing Loss on the Implanted Ear(s) With the Ponto 3 SuperPower for Patients With CHL/MHL.
PTA 4
|
-0.22 Effective gain Aided - BC In-situ [dB]
Standard Deviation 7.96
|
-0.36 Effective gain Aided - BC In-situ [dB]
Standard Deviation 8.5
|
—
|
|
Degree of Compensation for Hearing Loss on the Implanted Ear(s) With the Ponto 3 SuperPower for Patients With CHL/MHL.
500 Hz
|
4.09 Effective gain Aided - BC In-situ [dB]
Standard Deviation 9.88
|
5.71 Effective gain Aided - BC In-situ [dB]
Standard Deviation 8.38
|
—
|
|
Degree of Compensation for Hearing Loss on the Implanted Ear(s) With the Ponto 3 SuperPower for Patients With CHL/MHL.
1000 Hz
|
-2.42 Effective gain Aided - BC In-situ [dB]
Standard Deviation 10.01
|
-2.14 Effective gain Aided - BC In-situ [dB]
Standard Deviation 8.59
|
—
|
|
Degree of Compensation for Hearing Loss on the Implanted Ear(s) With the Ponto 3 SuperPower for Patients With CHL/MHL.
2000 Hz
|
-0.46 Effective gain Aided - BC In-situ [dB]
Standard Deviation 9.95
|
-1.43 Effective gain Aided - BC In-situ [dB]
Standard Deviation 11.07
|
—
|
|
Degree of Compensation for Hearing Loss on the Implanted Ear(s) With the Ponto 3 SuperPower for Patients With CHL/MHL.
3000 Hz
|
1.45 Effective gain Aided - BC In-situ [dB]
Standard Deviation 9.68
|
-0.71 Effective gain Aided - BC In-situ [dB]
Standard Deviation 9.76
|
—
|
|
Degree of Compensation for Hearing Loss on the Implanted Ear(s) With the Ponto 3 SuperPower for Patients With CHL/MHL.
4000 Hz
|
-2.03 Effective gain Aided - BC In-situ [dB]
Standard Deviation 9.74
|
-3.57 Effective gain Aided - BC In-situ [dB]
Standard Deviation 12.82
|
—
|
SECONDARY outcome
Timeframe: Visit 2, 3 monthsGlasgow Benefit Inventory (GBI) total score per target population. The GBI consists of 18 items, each on a 5 point Likert scale. Responses are scaled and averaged to give a score with a range -100 (poorest outcome) through 0 (no change) to +100 (best outcome).
Outcome measures
| Measure |
Target Population 1 - CHL/MHL
n=46 Participants
TP 1 - Conductive Hearing Loss (CHL) / Mixed Hearing Loss (MHL) within indication.
|
Target Population 2 - Bilateral
n=8 Participants
TP 2 Patients with CHL/MHL who were bilaterally fitted.
|
Target Population 3 - SSD
n=3 Participants
TP3 - Single Sided Deafness (SSD) within indication
|
|---|---|---|---|
|
Quality of Life Improvements With the Ponto 3 SuperPower
|
53.9 units on a scale
Standard Deviation 20.9
|
56.4 units on a scale
Standard Deviation 26.6
|
41.9 units on a scale
Standard Deviation 24.3
|
SECONDARY outcome
Timeframe: Change between visit 1 (day 1) and visit 2 (3 months)t of studyPopulation: Functional gain for CHL/MHL based on PTA4 was not available for all individuals. Speech recognition in noise was measured aided and unaided for only one SSD patient within indication (TP3 - SSD).
Improved hearing was analyzed as the percentage of subjects whose performance is better or equal in the unaided to aided comparisons, i.e., have a difference ≥0. Functional gain was used for CHL/MHL patients and speech recognition in noise was used for SSD patients.
Outcome measures
| Measure |
Target Population 1 - CHL/MHL
n=33 Participants
TP 1 - Conductive Hearing Loss (CHL) / Mixed Hearing Loss (MHL) within indication.
|
Target Population 2 - Bilateral
n=7 Participants
TP 2 Patients with CHL/MHL who were bilaterally fitted.
|
Target Population 3 - SSD
n=1 Participants
TP3 - Single Sided Deafness (SSD) within indication
|
|---|---|---|---|
|
Individual Level Evaluation of Objectives 1-6; Improved Hearing
|
33 Participants
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 1 day 1Population: This variable is specific for patients with CHL/MHL only and thus not applicable for those with single-sided deafness, i.e., Target Population 3 - SSD.
The difference between masked (if not available unmasked) BC and AC thresholds (unaided), denoted 'air to bone gap', calculated for frequencies 500, 1000, and 2000 Hz for the patients with CHL/MHL within indication on the implanted ear. For bilateral patients, the best ear was selected. Only participants that had complete data for these frequencies were included in the analysis.
Outcome measures
| Measure |
Target Population 1 - CHL/MHL
n=46 Participants
TP 1 - Conductive Hearing Loss (CHL) / Mixed Hearing Loss (MHL) within indication.
|
Target Population 2 - Bilateral
n=8 Participants
TP 2 Patients with CHL/MHL who were bilaterally fitted.
|
Target Population 3 - SSD
TP3 - Single Sided Deafness (SSD) within indication
|
|---|---|---|---|
|
Air to Bone Gap (PTA3) on the Implanted Ear(s) for Patients With CHL/MHL
PTA3
|
33.6 Air to bone gap AC - BC [dB]
Standard Deviation 12.4
|
21.7 Air to bone gap AC - BC [dB]
Standard Deviation 16.7
|
—
|
|
Air to Bone Gap (PTA3) on the Implanted Ear(s) for Patients With CHL/MHL
500 Hz
|
37.7 Air to bone gap AC - BC [dB]
Standard Deviation 17.9
|
25.0 Air to bone gap AC - BC [dB]
Standard Deviation 18.0
|
—
|
|
Air to Bone Gap (PTA3) on the Implanted Ear(s) for Patients With CHL/MHL
1000 Hz
|
37.4 Air to bone gap AC - BC [dB]
Standard Deviation 13.1
|
30.0 Air to bone gap AC - BC [dB]
Standard Deviation 20.0
|
—
|
|
Air to Bone Gap (PTA3) on the Implanted Ear(s) for Patients With CHL/MHL
2000 Hz
|
25.7 Air to bone gap AC - BC [dB]
Standard Deviation 13.1
|
15.0 Air to bone gap AC - BC [dB]
Standard Deviation 14.1
|
—
|
SECONDARY outcome
Timeframe: Visit 2, 3 monthsPopulation: For Target Population 2 - Bilateral both treated ears are considered.
Skin condition around the abutment was assessed via Holgers score (scale 0-4). Holgers 0: No skin reaction Holgers 1: Redness with slight swelling Holgers 2: Redness, moistness, and moderate swelling Holgers 3: Redness, moistness, and moderate swelling with tissue granulation Holgers 4: Profound signs of infection, resulting in removal of the implant Only participants who had recorded Holgers score in record were analyzed.
Outcome measures
| Measure |
Target Population 1 - CHL/MHL
n=36 Number of ears
TP 1 - Conductive Hearing Loss (CHL) / Mixed Hearing Loss (MHL) within indication.
|
Target Population 2 - Bilateral
n=16 Number of ears
TP 2 Patients with CHL/MHL who were bilaterally fitted.
|
Target Population 3 - SSD
n=2 Number of ears
TP3 - Single Sided Deafness (SSD) within indication
|
|---|---|---|---|
|
Skin Condition Assessment Around the Abutment
Holger's score 0-1
|
35 Number of ears
|
15 Number of ears
|
2 Number of ears
|
|
Skin Condition Assessment Around the Abutment
Holger's score 2-4
|
1 Number of ears
|
1 Number of ears
|
0 Number of ears
|
Adverse Events
All Enrolled Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nicole Amichetti, PhD, MS, Manager of Clinical Affairs
Oticon Medical
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place