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Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant

NCT01738490 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2017-11-27

No results posted yet for this study

Summary

The overall aim of the study is to investigate the Ponto wide implant considering; initial implant stability, stability over time, skin reaction and long term success when loaded at 3 weeks post surgery. Patients' quality of life improvements following implantation will also be surveyed.

More specifically the primary objective of this clinical study is to test the hypothesis

* The new Ponto wide diameter implant offers increased implant stability measured as ISQ (implant stability quotient) compared to the previous generation Ponto implant.

And the secondary objective is to

* Investigate when in time implant stability is the lowest as the initial mechanical stability is gradually replaced by biological stability

Conditions

  • Deafness
  • Hearing Loss
  • Hearing Loss, Conductive
  • Hearing Disorders
  • Ear Diseases
  • Otorhinolaryngologic Diseases

Interventions

DEVICE

Bone anchored hearing implant

Sponsors & Collaborators

  • Oticon Medical

    lead INDUSTRY

Principal Investigators

  • Myrthe KS Hol, MD, PhD · University Medical Center St Radboud, Nijmegen, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-06-30
Completion
2016-12-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

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 NCT01738490 on ClinicalTrials.gov