Hearing Loss, ConductiveNCT04803279
Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear
An observational study of Hearing Loss, Conductive and Hearing Loss Mixed, run by Oticon Medical at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Conductive, Hearing Loss Mixed, Hearing Disability
- What is being tested?
- Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower, Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPower and Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower
- Type of treatment
- Medical device
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Mar 2021to 8 Jun 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- Subjects who have consented to Section 3 of the document: "GDPR - what this means to you" (Appendix A) as part of a clinical routine visit.
- Fitted unilaterally or bilaterally with the Ponto 3 SuperPower(s) on abutment(s)
- Adult subjects (18 years or older)
- Patient has attended a clinical routine visit where fitting of Ponto 3 SuperPower has been performed and at least one following clinical routine visit where audiological measurements has been performed
Who cannot join
- There are no exclusion criteria in this study due to the retrospective nature of the study.
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
About this study
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.
Read more
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).
- Conditions
- Hearing Loss, Conductive, Hearing Loss Mixed, Hearing Disability, Conductive Hearing Loss, Ear Diseases, Conductive Hearing Loss, Bilateral
- Being tested
- Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower, Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPower, Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower, Collection of speech intelligibility scores, Skin reaction
- Medical subject headings
- Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Ear Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPowerDevice
Unmasked and if available masked BC thresholds from audiogram obtained prior to Ponto 3 SuperPower were fitted.
Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPowerDevice
BC In-situ thresholds will be collected from the BC In-situ audiogram obtained when Ponto 3 SuperPower were fitted
Collection of Aided sound field thresholds measured with the Ponto 3 SuperPowerDevice
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
Collection of speech intelligibility scoresDevice
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.
Skin reactionDevice
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
Collection of Glasgow Benefit InventoryDevice
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.
Collection of power-on usage time with Ponto 3 SuperPowerDevice
Average power-on usage hours from Ponto 3 SuperPower will be collected.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 2, 3 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Visit 2, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start16 Mar 2021
- Primary completion8 Jun 2021
- Study completion8 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, ConductiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John E FitzGerald, Bsc Phd, Principal investigator, Norfolk & Norwich University Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803279
- Sponsor's protocol ID
- BC107
- Status last verified
- Aug 2025
- First submitted
- 15 Mar 2021
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear
- ClinicalTrials.gov ID
- NCT04803279
- Acronym / sponsor ID
- BC107
- Conditions
- Hearing Loss, Conductive, Hearing Loss Mixed, Hearing Disability, Conductive Hearing Loss, Ear Diseases, Conductive Hearing Loss, Bilateral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 8 Jun 2021 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ponto 3 SuperPower users | – | 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 SuperPowerPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- Subjects who have consented to Section 3 of the document: "GDPR - what this means to you" (Appendix A) as part of a clinical routine visit.
- Fitted unilaterally or bilaterally with the Ponto 3 SuperPower(s) on abutment(s)
- Adult subjects (18 years or older)
- Patient has attended a clinical routine visit where fitting of Ponto 3 SuperPower has been performed and at least one following clinical routine visit where audiological measurements has been performed
Key exclusion criteria (2 listed)
- There are no exclusion criteria in this study due to the retrospective nature of the study.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPowerUnmasked and if available masked BC thresholds from audiogram obtained prior to Ponto 3 SuperPower were fitted. | Device | Ponto 3 SuperPower users |
| Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPowerBC In-situ thresholds will be collected from the BC In-situ audiogram obtained when Ponto 3 SuperPower were fitted | Device | Ponto 3 SuperPower users |
| Collection of Aided sound field thresholds measured with the Ponto 3 SuperPowerSound 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 | Device | Ponto 3 SuperPower users |
| Collection of speech intelligibility scoresSpeech 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. | Device | Ponto 3 SuperPower users |
| Skin reactionClassification 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 | Device | Ponto 3 SuperPower users |
| Collection of Glasgow Benefit InventoryThe 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. | Device | Ponto 3 SuperPower users |
| Collection of power-on usage time with Ponto 3 SuperPowerAverage power-on usage hours from Ponto 3 SuperPower will be collected. | Device | Ponto 3 SuperPower users |
Primary outcome
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).
Time frame: Visit 2, 3 months
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.
8 secondary outcomes
Functional Gain With the Ponto 3 SuperPower for Patients With CHL/MHL.
Time frame: Visit 1, Day 1
Improvement of Speech Recognition in Quiet and in Noise With Ponto 3 SuperPower for Patients With CHL/MHL
Time frame: Visit 2, 3 months
Speech Recognition in Noise Improvements With Ponto 3 SuperPower on for Patients With SSD
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.
Time frame: visit 2, 3 months
Quality of Life Improvements With the Ponto 3 SuperPower
Time frame: Visit 2, 3 months
Individual Level Evaluation of Objectives 1-6; Improved Hearing
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
Time frame: Visit 1 day 1
Skin Condition Assessment Around the Abutment
Time frame: Visit 2, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John E FitzGerald, Bsc Phd principal investigator
Norfolk & Norwich University Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Conductive and Hearing Loss Mixed, run by Oticon Medical at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Visit 2, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.