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NCT01671176 · ClinicalTrials.gov registry record · NA
Wide Diameter Bone Anchored Implant Study
A NA study of Conductive Hearing Loss and Conductive and Sensori-neural Hearing Loss in the Same Ear, sponsored by Oticon Medical.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT01671176: Completed NA study of Conductive Hearing Loss and Conductive and Sensori-neural Hearing Loss in the Same Ear, sponsored by Oticon Medical.
NCT01671176 is a NA study of Conductive Hearing Loss and Conductive and Sensori-neural Hearing Loss in the Same Ear that has completed, run by Oticon Medical. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01671176, a NA study of Conductive Hearing Loss and Conductive and Sensori-neural Hearing Loss in the Same Ear, has completed, sponsored by Oticon Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study 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
Primary Outcome
Holger's Scale is a 5 point that ranges from 0 - 4 scale that assesses skin reactions at the implant site where 0 means no reaction and 4 means excessive granulation, skin overgrowth, or scar formation requiring revision surgery
Conditions Studied
Interventions
- DEVICE Wide diameter bone anchored implant
Study Locations (2)
Florida
- Silverstein Institute - Sarasota
Michigan
- Michigan Ear Institute - Farmington Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-11 |
| Phase | NA |
What the finished NCT01671176 record still lists
NCT01671176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Conductive Hearing Loss appearing as the primary indexed condition, and to 1 intervention - of which Wide diameter bone anchored implant is the first listed.
NCT01671176 reports a single indexed study location in Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT01671176 about?
NCT01671176 is a clinical study titled "Wide Diameter Bone Anchored Implant Study". 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 o...
What is the current status of trial NCT01671176?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2012-05. Estimated completion is 2014-11.
What conditions does trial NCT01671176 study?
This clinical trial studies the following conditions: Conductive Hearing Loss, Conductive and Sensori-neural Hearing Loss in the Same Ear, Unilateral, Profound Sensori-neural Hearing Loss.
What interventions are being tested in trial NCT01671176?
The interventions under investigation include: Wide diameter bone anchored implant (DEVICE).
Who is sponsoring clinical trial NCT01671176?
This trial is sponsored by Oticon Medical, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01671176 being conducted?
This trial has 2 study locations across Florida, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01671176's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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