Status:
COMPLETED
Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid
Lead Sponsor:
Oticon Medical
Conditions:
Hearing Loss, Conductive
Hearing Loss, Mixed
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
The study is a combined retrospective (fitting visit) and prospective (study visit), multi-center, single arm study The study is part of the Post Market Clinical Follow (PMCF) activity. The investigat...
Detailed Description
This is a post market clinical follow up (PMCF) study with the purpose of gather knowledge on the use and performance of the Ponto 4 device on existing Ponto 4 users. The study does not include any tr...
Eligibility Criteria
Inclusion
- Signed Informed Consent Form
- 12 years old and above
- Subjects with hearing loss fitted unilaterally or bilaterally with the Ponto 4(s) on abutment at least 1.5 months prior to being enrolled in the study
- Fluent in local language, as judged by the investigator
Exclusion
- Participation in another clinical investigation which might cause interference with study participation.
- Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g. to complete patient related outcome (PRO's) according to investigators discretion
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04761926
Start Date
January 15 2021
End Date
February 24 2021
Last Update
July 31 2025
Active Locations (1)
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1
Aalborg University Hospital
Aalborg, Denmark, 9000