Cross-sectional Evaluation of the Subjective Performance and Satisfaction With Ponto Sound Processors
BC112
BC112 Cross-sectional Evaluation of the Subjective Performance and Satisfaction With Ponto Sound Processors
1 other identifier
observational
170
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 11, 2022
CompletedFirst Submitted
Initial submission to the registry
April 26, 2022
CompletedFirst Posted
Study publicly available on registry
May 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedResults Posted
Study results publicly available
August 17, 2025
CompletedAugust 17, 2025
July 1, 2025
2.4 years
April 26, 2022
March 13, 2025
July 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
at enrollment
Secondary Outcomes (11)
Factor 1 IOI-HA Score
at enrollement
Factor 2 IOI-HA Score
at enrollment
Per Item IOI-HA Score (Q1)
at enrollment
Per Item IOI-HA Score (Q2)
at enrollment
Per Item IOI-HA Score (Q3)
at enrollment
- +6 more secondary outcomes
Study Arms (1)
Ponto Users
Users that have been fitted with a Bone Anhcored Sound Processor, Ponto
Interventions
Bone Anchored Hearing solution fitted to compensate for the subjects hearing loss
Eligibility Criteria
Users fitted with a Ponto sound processor
You may qualify if:
- Online consent form filled out Has been fitted with at least one Ponto Sound Processor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oticon Medicallead
Study Sites (1)
Oticon Medical
Somerset, New Jersey, 08873, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Survey study
Results Point of Contact
- Title
- Dr. Nicole Amichetti
- Organization
- Oticon Medical
Study Officials
- STUDY DIRECTOR
Marianne Philipsson
Oticon Medical
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2022
First Posted
May 2, 2022
Study Start
April 11, 2022
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
August 17, 2025
Results First Posted
August 17, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share