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Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation

NCT02064478 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2018-02-22

No results posted yet for this study

Summary

A bone anchored hearing system is used to improve hearing for patients with e.g. conductive/mixed hearing loss or single sided deafness.

With this type of system, a titanium implant is installed in the temporal bone, where it osseointegrates, i.e. integrates with the bone. An abutment (also in titanium) is attached to the implants and penetrates the skin. The sound processor (hearing aid) is then connected to the abutment, and can be attached and removed by the patient via a snap-coupling. This type of system has been successfully implanted in more than 100.000 patients. Recently, a simplified surgical procedure, where no skin thinning around the abutment is made, was approved. The results after using this installation technique, here called soft tissue preservation, are the focus of this study.

The objective of the study is to compare the outcomes after a surgical procedure with soft tissue preservation (test) and a surgery with soft tissue reduction (control) for placing Oticon Medical Ponto implants and abutments. The main hypothesis is that patient numbness around the implant is less in the test group compared to the control group.

Conditions

  • Conductive Hearing Loss
  • Mixed Hearing Loss
  • Single Sided Deafness

Sponsors & Collaborators

  • Statistiska Konsultgruppen

    collaborator OTHER

  • Oticon Medical

    lead INDUSTRY

Principal Investigators

  • Myrthe KS Hol, MD, PhD · Radboud University Medical Center

  • Emmanuel AM Mylanus, MD, PhD · Radboud University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-04-30
Completion
2017-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02064478 on ClinicalTrials.gov