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

Cochlear

Status: Completed

Conditions: Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural; Hearing Loss; Deafness

Treatments: Device: Traditional surgery and BA300; Device: Minimally invasive surgery and BA400

Study type: Interventional

Funder types: Industry

Identifiers

NCT01796236

CBAS5439

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Minimally invasive surgery and BA400

Active Comparator group

Description:

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

Treatment:

Device: Minimally invasive surgery and BA400

Traditional surgery and BA300

Active Comparator group

Description:

This arm involves traditional soft tissue reduction around the BA300 implant

Treatment:

Device: Traditional surgery and BA300