Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-09

Study Completion Date

2020-12-21

Brief Summary

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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 Medical Ponto implants and abutments.

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Detailed Description

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Conditions

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Bone Conduction Deafness Unilateral Deafness Middle Ear Deafness Mixed Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Minimally Invasive Ponto Surgery

Surgical method for installation of a bone anchored hearing system for hearing rehabilitation

Group Type OTHER

Minimally Invasive Ponto Surgery

Intervention Type DEVICE

Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implant in patients indicated and counselled for Bone Anchored Hearing System.

Interventions

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Minimally Invasive Ponto Surgery

Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implant in patients indicated and counselled for Bone Anchored Hearing System.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No