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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ponto 3 SuperPower users | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower | Device | Unmasked and if available masked BC thresholds from audiogram obtained prior to Ponto 3 SuperPower were fitted. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 2, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 1, Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
There are no exclusion criteria in this study due to the retrospective nature of the study.
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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
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| Name | Affiliation | Role |
|---|---|---|
| John E FitzGerald, Bsc Phd | Norfolk & Norwich University Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norfolk and Norwich University Hospitals NHS Foundation Trust | Norwich | Norfolk | NR4 7UY | United Kingdom |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Target Population 1 - CHL/MHL | CHL/MHL within indication |
| FG001 | Target Population 2 - CHL/MHL Bilateral | Bilateral CHL/MHL within indication |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 30, 2021 | Nov 4, 2022 |
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| Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPower | Device | BC In-situ thresholds will be collected from the BC In-situ audiogram obtained when Ponto 3 SuperPower were fitted |
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| Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower | Device | 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 |
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| Collection of speech intelligibility scores | Device | 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. |
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| Skin reaction | Device | 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 |
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| Collection of Glasgow Benefit Inventory | Device | 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. |
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| Collection of power-on usage time with Ponto 3 SuperPower | Device | Average power-on usage hours from Ponto 3 SuperPower will be collected. |
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| 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. |
| 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. | 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. | 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). | 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. | 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. | 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. | Visit 2, 3 months |
| FG002 | Target Population 3 - SSD | SSD within indication (TP3 - SSD) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Target Population 1 - CHL/MHL | TP 1 - Conductive Hearing Loss (CHL) / Mixed Hearing Loss (MHL) within indication. |
| BG001 | Target Population 2 - Bilateral | TP 2- Patients with CHL/MHL who were bilaterally fitted. |
| BG002 | Target Population 3 - SSD | TP 3 - Single Sided Deafness (SSD) within indication |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| 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 | 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. | Measurement not applicable for Target Population 3 - SSD | Posted | Mean | Standard Deviation | dB | Visit 2, 3 months |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Functional gain Unaided (AC) - Aided [dB | Visit 1, Day 1 |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | percent correct words | Visit 2, 3 months |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | percent correct words | Visit 2, 3 months |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Effective gain Aided - BC In-situ [dB] | visit 2, 3 months |
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| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | Visit 2, 3 months |
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| Secondary | 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. | 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). | Posted | Count of Participants | Participants | Change between visit 1 (day 1) and visit 2 (3 months)t of study |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Air to bone gap AC - BC [dB] | Visit 1 day 1 |
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| Secondary | 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. | For Target Population 2 - Bilateral both treated ears are considered. | Posted | Count of Units | Number of ears | Visit 2, 3 months | Number of ears | Number of ears |
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Not applicable due to the retrospective nature of the study.
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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 | All Enrolled Participants | Existing Ponto 3 SuperPower users who were 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. The adverse events are reported for all participants as a single group rather than by the analysis groups, primarily as this was a retrospective study design and furthermore one would not expect differences in hearing loss etiology (again, the analysis groups) would result in differences in adverse events in this retrospective study. | 0 | 57 | 0 | 57 | 0 | 57 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Amichetti, PhD, MS, Manager of Clinical Affairs | Oticon Medical | 6093660424 | nitc@oticonmedical.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 24, 2021 | Nov 4, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| D004427 | Ear Diseases |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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