Clinical Survey of Different Abutment Topologies

Oticon Medical

Status: Completed

Conditions: Mixed Hearing Loss; Unilateral Partial Deafness; Conductive Hearing Loss

Treatments: Device: Bone anchored hearing aid

Study type: Interventional

Funder types: Industry

Identifiers

NCT02304692

C49

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Oticon Medical Machined Abutment

Sham Comparator group

Description:

A non surface modified abutment is used

Treatment:

Device: Bone anchored hearing aid

Oticon Medical Modified Abutment

Experimental group

Description:

A surface modified abutment is used

Treatment:

Device: Bone anchored hearing aid