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Clinical Trials/NL-OMON38035
NL-OMON38035
Completed
Not Applicable

Clinical survey of Oticon Medical Ponto implants and a surgical technique with tissue preservation - Oticon tissue preservation study

Oticon Medical AB0 sites25 target enrollmentTBD
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ConditionsBone Anchored Hearing AidBone Implant10019243

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bone Anchored Hearing Aid
Sponsor
Oticon Medical AB
Enrollment
25
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
October 1, 2018
Last Updated
2 years ago
Study Type
Observational non invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\* 18 years or older
  • •\* Patient indicated for an ear level bone anchored sound processor
  • •\* Bone thickness at the implant site of at least 4 mm
  • •\* Written informed consent

Exclusion Criteria

  • •\* Inability to participate in follow\-up
  • •\* Psychiatric disease in the medical history
  • •\* Mental disability
  • •\* Presumed doubt, for any reason, that the patient will be able to show up on all follow ups
  • •\* Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
  • •\* Patients with natural skin height of \>10 mm (as there will be additional skin reduction needed)

Outcomes

Primary Outcomes

Not specified

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