N/A
Completed N=30
Wide Diameter Bone Anchored Implant Study
Conductive Hearing Loss · Conductive and Sensori-neural Hearing Loss in the Same Ear · Unilateral, Profound Sensori-neural Hearing Loss
Source: ClinicalTrials.gov NCT01671176 ↗
Enrolled (actual)
30
Serious AEs
3.3%
Results posted
May 2018
Primary outcomePrimary: Holger's Scale — 29; 0; 1; 29 participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Holger's Scale |
29; 0; 1; 29; 1; 0 | — |
| PRIMARY Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane |
58.43; 58.58; 59.70; 59.77; 60.53; 60.30 | — |
Eligibility Criteria
Inclusion Criteria
- conductive, mixed or single sided deafness
- 18 years of age or older
Exclusion Criteria
- younger than 18 years of age
Data sourced from ClinicalTrials.gov (NCT01671176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.