An observational study in Hearing Loss, Conductive, Hearing Loss Mixed and Hearing Disability, sponsored by Oticon Medical. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-26.
Sponsored by Oticon Medical · Observational
The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device is the CE-marked Ponto 3 SuperPower (available on the market since December 2016) already fitted to the subjects, and data is collected retrospectively from clinical routine visits.
The study is a retrospective study. Therefore there will be no study visits for treatment or follow-up in the study.
Subject inclusion for this clinical investigation will be performed among subjects who has been fitted with the Ponto 3 SuperPower. To have a wide representative selection of subjects, enrollment will be spread over the 4 years since the device was available on the market since December 2016.
The endpoints in the study will investigate the improvement of hearing with the Ponto 3 SuperPower.
The data will be collected from the subjects in the time period from the clinical routine visit where the Ponto 3 SuperPower where fitted or just prior, and from the clinical routine visit following the fitting, where audiologic fitting follow-up procedures are performed (approximately 3 months).
82 studies on the registry are indexed under Hearing Loss, Conductive; 15 are open to participants now.
This study's enrollment of 57 is below the median of 71 across 20 observational studies indexed under Hearing Loss, Conductive.
Browse Hearing Loss, Conductive studies →Oticon Medical is the lead sponsor of 45 studies on the registry; 6 are open to participants now.
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Data collected from patients, who are Ponto 3 SuperPower users, and who have attended the Audiology Clinic at Norfolk and Norwich University Hospital (NNUH),Colney Ln, Norwich NR4 7UY, UK, in the period 2016-2020
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
There are no exclusion criteria in this study due to the retrospective nature of the study.
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Patients who are fitted either unilaterally or bilaterally on abutment since the device came to the market in 2016, and who have followed the clinics normal routine fitting and follow up visits. They must also have undergone the normal procedures performed as part of the clinics routine for fitting and following up. Data was collected from these routine visits.
Device: Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower · Device: Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPower · Device: Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower · Device: Collection of speech intelligibility scores · Device: Skin reaction · Device: Collection of Glasgow Benefit Inventory · Device: Collection of power-on usage time with Ponto 3 SuperPower
Unmasked and if available masked BC thresholds from audiogram obtained prior to Ponto 3 SuperPower were fitted.
BC In-situ thresholds will be collected from the BC In-situ audiogram obtained when Ponto 3 SuperPower were fitted
Sound field thresholds for frequencies 500Hz, 1kHz, 2 kHz, 3kHz and 4kHz will be collected from sound field audiogram obtained as follow-up after Ponto 3 SuperPower fitting, typically this is collected 3 months post fitting, alternatively from the fitting visit. Thresholds will be obtained aided, and when available unaided
Speech intelligibility is measured in a sound treated room using sentence tests. The sentence tests used at Norwich and Norfolk hospital is the BKB (Bamford-Kowal-Bench) and/or the The AB\[s\] Isophonemic Monosyllabic Word test (7). The sentence tests are measured in quiet and/or with background speech-weighted noise.
Classification of skin reactions around skin penetrating implants will be made using the Holgers score. The Holgers classification is a scale from 0 to 4 that is used to grade skin reactions
The Glasgow Benefit Inventory (GBI) contains 18 health status questions, which ask specific questions about how the health problem, in this study hearing loss, has affected their quality of life at the time the GBI is completed. In this study GBI has been collected on patients before intervention and 3 months after fitting of Ponto 3 SuperPower on abutment.
Average power-on usage hours from Ponto 3 SuperPower will be collected.
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 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.
Time frame: Visit 2, 3 months
Functional Gain With the Ponto 3 SuperPower for Patients With CHL/MHL.
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.
Time frame: Visit 1, Day 1
Improvement of Speech Recognition in Quiet and in Noise With Ponto 3 SuperPower for Patients With CHL/MHL
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.
Time frame: Visit 2, 3 months
Speech Recognition in Noise Improvements With Ponto 3 SuperPower on for Patients With 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.
Time frame: Visit 2, 3 months
Degree of Compensation for Hearing Loss on the Implanted Ear(s) With the Ponto 3 SuperPower for Patients With CHL/MHL.
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.
Time frame: visit 2, 3 months
Quality of Life Improvements With the Ponto 3 SuperPower
Glasgow 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).
Time frame: Visit 2, 3 months
Individual Level Evaluation of Objectives 1-6; Improved Hearing
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.
Time frame: Change between visit 1 (day 1) and visit 2 (3 months)t of study
Air to Bone Gap (PTA3) on the Implanted Ear(s) for Patients With CHL/MHL
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.
Time frame: Visit 1 day 1
Skin Condition Assessment Around the Abutment
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.
Time frame: Visit 2, 3 months
| Milestone | Target Population 1 - CHL/MHL | Target Population 2 - CHL/MHL Bilateral | Target Population 3 - SSD |
|---|---|---|---|
| Started | 46 | 8 | 3 |
| Completed | 46 | 8 | 3 |
| Not completed | 0 | 0 | 0 |
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.
| dB | Target Population 1 - CHL/MHL | Target Population 2 - Bilateral | Target Population 3 - SSD |
|---|---|---|---|
| Unaided AC [dB] | 70.2 ± 17.9 | 64.2 ± 19.4 | — |
| Aided sound field [dB] | 35.6 ± 9.0 | 35.2 ± 4.2 | — |
| Functional gain Unaided (AC) - Aided [dB] | 36.0 ± 13.9 | 31.9 ± 15.4 | — |
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.
| Functional gain Unaided (AC) - Aided [dB | Target Population 1 - CHL/MHL | Target Population 2 - Bilateral | Target Population 3 - SSD |
|---|---|---|---|
| 500 Hz | 38.3 ± 17.6 | 35.0 ± 12.9 | — |
| 1000 Hz | 37.4 ± 15.8 | 35.7 ± 15.7 | — |
| 2000 Hz | 31.7 ± 17.1 | 26.4 ± 16.8 | — |
| 3000 Hz | 34.2 ± 18.2 | 32.1 ± 24.5 | — |
| 4000 Hz | 37.0 ± 16.5 | 35.0 ± 21.2 | — |
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.
| percent correct words | Target Population 1 - CHL/MHL | Target Population 2 - Bilateral | Target Population 3 - SSD |
|---|---|---|---|
| BKB Sentence Test in Noise | 73.5 ± 19.0 | 66.5 ± 23.8 | — |
| BKB Sentence Test in Quiet | 88.6 ± 11.3 | 91.5 ± 7.1 | — |
| AB[s] short list in Noise | 67.6 ± 21.0 | 59.0 ± 21.8 | — |
| AB[s] short list in Quiet | 84.1 ± 18.7 | 87.7 ± 9.3 | — |
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.
| percent correct words | Target Population 1 - CHL/MHL | Target Population 2 - Bilateral | Target Population 3 - SSD |
|---|---|---|---|
| Aided SimplatedNnon-implanted - % correct | — | — | 60.0 ± 9.5 |
| Unaided SimplatedNnon-implanted - % correct | — | — | 36.7 ± 0 |
| Difference: Aided - Unaided SimplatedNnon-implanted - % correct | — | — | 30.0 ± 0 |
| Aided Snon-implatedNimplanted - % correct | — | — | 80.0 ± 23.6 |
| Unaided Snon-implatedNimplanted - % correct | — | — | 91.3 ± 0 |
| Difference: Aided- Unaided Snon-implatedNimplanted - % correct | — | — | 5.40 ± 0 |
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.
| Effective gain Aided - BC In-situ [dB] | Target Population 1 - CHL/MHL | Target Population 2 - Bilateral | Target Population 2 - SSD |
|---|---|---|---|
| PTA 4 | -0.22 ± 7.96 | -0.36 ± 8.5 | — |
| 500 Hz | 4.09 ± 9.88 | 5.71 ± 8.38 | — |
| 1000 Hz | -2.42 ± 10.01 | -2.14 ± 8.59 | — |
| 2000 Hz | -0.46 ± 9.95 | -1.43 ± 11.07 | — |
| 3000 Hz | 1.45 ± 9.68 | -0.71 ± 9.76 | — |
| 4000 Hz | -2.03 ± 9.74 | -3.57 ± 12.82 | — |
Glasgow 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).
| units on a scale | Target Population 1- CHL/MHL | Target Population 2 - Bilateral | Target Population 3 - SSD |
|---|---|---|---|
| Quality of Life Improvements With the Ponto 3 SuperPower | 53.9 ± 20.9 | 56.4 ± 26.6 | 41.9 ± 24.3 |
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.
| Participants | Target Population 1 - CHL/MHL | Target Group 2 - Bilateral | Target Population 3 - SSD |
|---|---|---|---|
| Individual Level Evaluation of Objectives 1-6; Improved Hearing | 33 | 7 | 1 |
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.
| Air to bone gap AC - BC [dB] | Target Population 1 - CHL/MHL | Target Population 2 - Bilateral | Target Population 3 - SSD |
|---|---|---|---|
| PTA3 | 33.6 ± 12.4 | 21.7 ± 16.7 | — |
| 500 Hz | 37.7 ± 17.9 | 25.0 ± 18.0 | — |
| 1000 Hz | 37.4 ± 13.1 | 30.0 ± 20.0 | — |
| 2000 Hz | 25.7 ± 13.1 | 15.0 ± 14.1 | — |
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.
| Number of ears | Target Population 1 - CHL/MHL | Target Population 2 - Bilateral | Target Population 3 - SSD |
|---|---|---|---|
| Holger's score 0-1 | 35 | 15 | 2 |
| Holger's score 2-4 | 1 | 1 | 0 |
Collected over Not applicable due to the retrospective nature of the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Enrolled Participants | 0/57 (0%) | 0/57 (0%) | 0/57 (0%) |
| Age, Continuous(years) | Target Population 1 - CHL/MHL | Target Population 2 - Bilateral | Target Population 3 - SSD | Total |
|---|---|---|---|---|
| Mean | 59.5 ± 16.4 | 63.5 ± 15.6 | 57.7 ± 4.7 | 60.6 ± 15.6 |
| Sex: Female, Male(Participants) | Target Population 1 - CHL/MHL | Target Population 2 - Bilateral | Target Population 3 - SSD | Total |
|---|---|---|---|---|
| Female | 30 | 7 | 1 | 38 |
| Male | 16 | 1 | 2 | 19 |
| Race and Ethnicity Not Collected(Participants) | Target Population 1 - CHL/MHL | Target Population 2 - Bilateral | Target Population 3 - SSD | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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