Hearing LossBC112NCT05356221
Cross-sectional Evaluation of the Subjective Performance and Satisfaction With Ponto Sound Processors
An observational study of Hearing Loss and Hearing Loss, Conductive, run by Oticon Medical at 1 site in United States.
Trial summary
The study is a non-interventional, observational, cross-sectional, study on users of Ponto sound processors. The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with Oticon Medical's sound processors fitted with the Genie Medical fitting software. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Unilateral
- What is being tested?
- Ponto Sound processor
- Type of treatment
- Medical device
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2022to 1 Sep 2024
- 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: Users fitted with a Ponto sound processor
Who may be able to join
- Online consent form filled out Has been fitted with at least one Ponto Sound Processor
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BC112 Cross-sectional Evaluation of the Subjective Performance and Satisfaction With Ponto Sound Processors
The study is a non-interventional, observational, cross-sectional, study on users of Ponto sound processors. The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with Oticon Medical's sound processors fitted with the Genie Medical fitting software.
Read the detailed description
The study is a non-interventional, observational, cross-sectional, study on users of Ponto sound processors. The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with Oticon Medical's sound processors fitted with the Genie Medical fitting software. Subjects fitted with one or two Ponto sound processors will be invited to participate in an online survey. The survey contains questions about the subjectively experienced performance and satisfaction of the device. The survey can be filled out on computer, tablet or mobile phone and should take the participants about 10 minutes to fill out.
- Being tested
- Ponto Sound processor
- Medical subject headings
- Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Unilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ponto Sound processorDevice
Bone Anchored Hearing solution fitted to compensate for the subjects hearing loss
| Study group | Role | What they receive |
|---|---|---|
| Ponto Users | Users that have been fitted with a Bone Anhcored Sound Processor, Ponto Receives: Device: Ponto Sound processor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall IOI-HA Score
International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1) to best outcome (5). Evaluate subjectively assessed overall hearing performance and satisfaction with the Oticon Medical's Ponto sound processors.
Measured: at enrollment
Secondary outcomes (11)
Factor 1 IOI-HA Score
Factor 1 International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1) to best outcome (5). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors
Measured: at enrollement
Factor 2 IOI-HA Score
Factor 2 International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1) to best outcome (5). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors
Measured: at enrollment
Per Item IOI-HA Score (Q1)
Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1) to best outcome (5). Here, this item queries average hours of use per day and a score of 1 is assigned for "none", a score of 2 assigned for "less than one hour per day", a score of 3 assigned for "1 to 4 hours per day", a score of 4 for "4 to 8 hours a day", and a score of 5 assigned for "more than 8 hours a day". Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors
Measured: at enrollment
Per Item IOI-HA Score (Q2)
Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: helped not at all) to best outcome (5: helped very much). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors
Measured: at enrollment
Per Item IOI-HA Score (Q3)
Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: Very much difficulty) to best outcome (5: No difficulty). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors
Measured: at enrollment
Per Item IOI-HA Score (Q4)
Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: Not worth it at all) to best outcome (5: Very much worth it). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors
Measured: at enrollment
Per Item IOI-HA Score (Q5)
Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: Affected very much) to best outcome (5: Affected not at all). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors
Measured: at enrollment
Per Item IOI-HA Score (Q6)
Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: bothered very much) to best outcome (5: Bothered not at all). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors
Measured: at enrollment
Per Item IOI-HA Score (Q7)
Per item International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1: Worse) to best outcome (5: Very much better). Evaluate the subjectively assessed performance and satisfaction with Oticon Medical's Ponto sound processors
Measured: at enrollment
Usage
Evaluate non-usage among patients fitted with a Ponto sound processor. Reported is number of participants by sound processor type.
Measured: at enrollment
Upgrade
Evaluate Ponto sound processor upgrade rate
Measured: enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start11 Apr 2022
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
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 LossStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marianne Philipsson, Study director, Oticon Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356221
- Sponsor's protocol ID
- BC112
- Acronym
- BC112
- Status last verified
- Jul 2025
- First submitted
- 26 Apr 2022
- Last updated
- 17 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BC112 Cross-sectional Evaluation of the Subjective Performance and Satisfaction With Ponto Sound Processors
- ClinicalTrials.gov ID
- NCT05356221
- Acronym / sponsor ID
- BC112 / BC112
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Posted 17 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 a non-interventional, observational, cross-sectional, study on users of Ponto sound processors. The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with Oticon Medical's sound processors fitted with the Genie Medical fitting software.
Detailed description
The study is a non-interventional, observational, cross-sectional, study on users of Ponto sound processors. The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with Oticon Medical's sound processors fitted with the Genie Medical fitting software. Subjects fitted with one or two Ponto sound processors will be invited to participate in an online survey. The survey contains questions about the subjectively experienced performance and satisfaction of the device. The survey can be filled out on computer, tablet or mobile phone and should take the participants about 10 minutes to fill out.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ponto Users | – | Device: Ponto Sound processorUsers that have been fitted with a Bone Anhcored Sound Processor, Ponto |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Users fitted with a Ponto sound processor
Key inclusion criteria (1 listed)
- Online consent form filled out Has been fitted with at least one Ponto Sound Processor
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Ponto Sound processorBone Anchored Hearing solution fitted to compensate for the subjects hearing loss | Device | Ponto Users |
Primary outcome
Overall IOI-HA Score
Time frame: at enrollment
International Outcome Inventory for Hearing Aids score. 5 item categorical scale ranging from worst outcome (1) to best outcome (5). Evaluate subjectively assessed overall hearing performance and satisfaction with the Oticon Medical's Ponto sound processors.
11 secondary outcomes
Factor 1 IOI-HA Score
Time frame: at enrollement
Factor 2 IOI-HA Score
Time frame: at enrollment
Per Item IOI-HA Score (Q1)
Time frame: at enrollment
Per Item IOI-HA Score (Q2)
Time frame: at enrollment
Per Item IOI-HA Score (Q3)
Time frame: at enrollment
Per Item IOI-HA Score (Q4)
Time frame: at enrollment
Per Item IOI-HA Score (Q5)
Time frame: at enrollment
Per Item IOI-HA Score (Q6)
Time frame: at enrollment
Per Item IOI-HA Score (Q7)
Time frame: at enrollment
Usage
Time frame: at enrollment
Upgrade
Time frame: enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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.
Marianne Philipsson study director
Oticon Medical
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 and Hearing Loss, Conductive, run by Oticon Medical at 1 site in United States.
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 1 inclusion and 1 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 17 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 States. 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 17 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?
Overall IOI-HA Score (time frame: at enrollment). 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 17 Aug 2025.