Status:
RECRUITING
Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)
Lead Sponsor:
Oticon Medical
Conditions:
Hearing Loss
Bone Anchored Hearing Aids
Eligibility:
All Genders
18+ years
Brief Summary
This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to inv...
Detailed Description
The study is observational and non interventional and follows clinical practice at participating clinics with the only exception of three questionnaires given to consenting patients after surgery and ...
Eligibility Criteria
Inclusion
- Adult subjects (≥18 years old) undergoing Ponto implantation in an out-of-OR setting from 2019 and onwards
- Signed informed consent (applicable for subjects answering questionnaires)
Exclusion
- No exclusion criteria have been set for this observational investigation
Key Trial Info
Start Date :
May 7 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT06930781
Start Date
May 7 2025
End Date
December 1 2026
Last Update
May 18 2025
Active Locations (2)
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1
Sunderby Sjukhus
Luleå, Norrbotten County, Sweden, 971 80
2
Skåne University Hospital
Lund, Skåne County, Sweden, 22185