Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive Surgical Technique

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2017-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection, overgrowth, pain and numbness at the site of implantation compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).

To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction in direct medical costs, due to shorter surgical procedures, faster wound healing and less complications compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System

NCT02092610

Conductive Hearing Loss

COMPLETED NA

Stability of the Cochlear Baha BI300/BA400 Implant System Loaded From 1 Week Post-surgery

NCT02096809

Hearing Loss - Conductive

COMPLETED NA

Comparative Study of Two Surgical Techniques for Soft Tissue Healing and Implant Stability of Cochlear BI300 Implants.

NCT01699620

Hearing Loss, Conductive

COMPLETED NA

Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha)

NCT01264510

Conductive Hearing Loss Mixed Hearing Loss Unilateral Deafness

WITHDRAWN PHASE4

Ponto Implantation Using a Minimally Invasive Surgical Technique

NCT04606823

Hearing Loss

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Despite extensive soft tissue reduction, the most common complications associated with Baha implants are related to adverse skin reactions around the abutment. The reduction of the skin also adds complexity to the surgical procedure that is otherwise a routine type of skin incision. A less invasive surgical technique avoiding reducing the thickness of the skin would render a simpler and shorter procedure and would be aesthetically appealing to the patients, as permanent hair removal in the area around the abutment would not be required. Faster healing and less numbness (sensory loss/ paraesthesia) at the implant site may also be expected if the soft tissue thickness is left intact.

The Cochlea Baha BA300 Abutment together with a surgical procedure that includes soft tissue reduction was CE marked in April 2010. The test abutment, Cochlear Baha BA400, together with a surgical procedure that does not require soft tissue reduction was CE marked in June 2012.

The rationale behind this investigation was to make a 'head-to-head' comparison between the BA300 and BA400 Abutment and the associated surgical techniques in order to collect information regarding complications (inflammation/infection, numbness and pain), aesthetic outcome and utilisation of direct medical cost associated with surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Deafness Hearing Loss Hearing Loss, Conductive Hearing Loss, Mixed Conductive-Sensorineural

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Minimally invasive surgery and BA400

This arm involves no soft tissue reduction around the BA400 implant.

Group Type ACTIVE_COMPARATOR

Minimally invasive surgery and BA400

Intervention Type DEVICE

The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).

Traditional surgery and BA300

This arm involves traditional soft tissue reduction around the BA300 implant

Group Type ACTIVE_COMPARATOR

Traditional surgery and BA300

Intervention Type DEVICE

The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Minimally invasive surgery and BA400

The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).

Intervention Type DEVICE

Traditional surgery and BA300

The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Eligible for the Baha system
* Signed informed consent

Exclusion Criteria

* Patient scheduled for simultaneously bilateral implant surgery
* Uncontrolled diabetes as judged by the investigator
* Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
* Unable to follow the cleaning instruction
* Unable to follow investigational procedures, e.g. to complete quality of life scales
* Participation in another investigation with pharmaceuticals and/or device
* Condition that may have an impact on the outcome of the investigation as judged by the investigator
* Suitable implant position for the 4 mm implant not found during surgery due to insufficient bone quality and/or bone thickness

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No