Wide Diameter Bone Anchored Implant Study

Completed · Not applicable

Conditions studied: Conductive Hearing Loss, Conductive and Sensori-neural Hearing Loss in the Same Ear, Unilateral, Profound Sensori-neural Hearing Loss

In brief

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

Key facts

Study ID

NCT01671176

Run by

Oticon Medical

People needed

30

Starts

2012-05-01

Expected to finish

2014-11-01

Last updated by the study team

2018-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• conductive, mixed or single sided deafness
• 18 years of age or older

You may not qualify if…

• younger than 18 years of age

Where it is running

• Silverstein Institute — Sarasota, Florida, United States
• Michigan Ear Institute — Farmington Hills, Michigan, United States

Full record on ClinicalTrials.gov

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