At a glance
ClinicalIndex Comparison RecordN/ACompleted· 30 enrolled
Drug / intervention
Wide diameter bone anchored implantdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Study of the Oticon Medical Ponto 4.5mm Wide Implant
In Brief
A clinical study evaluating Wide diameter bone anchored implant for Conductive Hearing Loss and 2 related conditions. Completed, enrolled 30 participants across 2 sites.
Detailed Summary
To assess implant stability, implant loss, adverse skin reactions, and Quality of Life Benefit following implantation of the Ponto 4.5mm Wide Diameter implant. Secondary: to determine the feasibility of fitting the sound processor 3 weeks after surgical implantation, and to investigate if the type of skin reactions following implantation could be related to the demographic data of subjects and the type of surgical technique used
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConductive Hearing Loss, Conductive and Sensori-neural Hearing Loss in the Same Ear, Unilateral, Profound Sensori-neural Hearing Loss
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2012
First PostedAug 2012
Primary CompletionNov 2014
TodayJul 2026
First PostedAug 23, 2012
Enrollment StartMay 1, 2012
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 13.9 years ago
Interventions
Wide diameter bone anchored implantdevice
4.5 mm wide diameter bone anchored implant