Clinical Survey of Different Abutment Topologies

NCT ID: NCT02304692

Last Updated: 2018-02-22

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-12-31

Brief Summary

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This study is designed to compare two different surfaces of bone anchored hearing aid abutments in terms of bacterial colonization, inflammatory response and skin reactions.

Detailed Description

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Conditions

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Conductive Hearing Loss Unilateral Partial Deafness Mixed Hearing Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oticon Medical Machined Abutment

A non surface modified abutment is used

Group Type SHAM_COMPARATOR

Bone anchored hearing aid

Intervention Type DEVICE

Oticon Medical Modified Abutment

A surface modified abutment is used

Group Type EXPERIMENTAL

Bone anchored hearing aid

Intervention Type DEVICE

Interventions

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Bone anchored hearing aid

Intervention Type DEVICE

Other Intervention Names

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BAHS BAHA

Eligibility Criteria

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Inclusion Criteria

* Any adult (18 years of age or older) patient eligible for a bone anchored hearing system

Exclusion Criteria

* Inability or unwillingness to participate in follow-up
* Skin thickness of \> 10 mm
* Diseases known to compromise bone quality
* Irradiated in the implant area
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oticon Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sofia Jonhede

Role: STUDY_CHAIR

Sponsor GmbH

Locations

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Department of Otorhinolaryngology, Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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C49

Identifier Type: -

Identifier Source: org_study_id

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