Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear
NCT ID: NCT04803279
Last Updated: 2025-08-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
57 participants
OBSERVATIONAL
2021-03-16
2021-06-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid
NCT04761926
Investigation of an Updated Bone-anchored Sound Processor
NCT05086809
Comparison of a New Bone Conduction Hearing System to a Osteo-integrated Bone Conduction Hearing Aid on a Softband
NCT03541967
Evaluation of the Benefits of Bilateral Fitting in BAHS Users
NCT04006132
Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant
NCT01738490
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower
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 SuperPower
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 SuperPower
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 scores
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 reaction
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 Inventory
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 SuperPower
Average power-on usage hours from Ponto 3 SuperPower will be collected.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower
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 SuperPower
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 SuperPower
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 scores
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 reaction
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 Inventory
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 SuperPower
Average power-on usage hours from Ponto 3 SuperPower will be collected.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Fitted unilaterally or bilaterally with the Ponto 3 SuperPower(s) on abutment(s)
3. Adult subjects (18 years or older)
4. 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
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Oticon Medical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John E FitzGerald, Bsc Phd
Role: PRINCIPAL_INVESTIGATOR
Norfolk & Norwich University Hospital NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BC107
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.