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COMPLETEDNANCT03281967

Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)

The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon M...

Lead sponsor: Oticon Medical•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Oticon Medical

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•18 years or older.
•Patient indicated for an ear level bone anchored sound processor.
•Healthy bone quality to allow for 4mm implant insertion.

Exclusion Criteria

•Intraoperative switch to an alternative surgical technique
•Patients undergoing re-implantation (on the side being included in the study)
•Previous participation in the C47 study.
•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 \>12mm (as there will be additional skin reduction needed)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 3, 2021Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment25

Start dateJun 2017

Last updatedMar 3, 2021

Condition

Bone Conduction Deafness Unilateral Deafness Middle Ear Deafness Mixed Hearing Loss

Locations shown

University Medical Center St Radboud

Nijmegen

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2021Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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