Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)

Cochlear

Status: Completed

Conditions: Hearing Loss, Conductive; Hearing Loss; Deafness

Treatments: Device: Baha Attract System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01822119

CBAS5484

Details and patient eligibility

About

The rationale behind this clinical performance investigation is to collect data regarding the usability of the Baha Attract System in patients with hearing impairment that are candidates for Baha surgery:

• To describe the expected hearing performance with the Baha Attract in comparison to unaided hearing thresholds or a pre-test situation using a sound processor together with a softband
• Which sound processor to select, i.e. BP100 vs BP110
• Improve the fitting process for the sound processor
• Selection of sound processor magnet at time of fitting and over time

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Conductive hearing loss in the implanted ear. Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz <30 decibel (dB) hearing level (HL)
• Single-sided Sensorineural Deafness (SSD). Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz <30 dB hearing level (HL) in the best ear
• Signed informed consent

Exclusion criteria

• 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 investigational procedures, e.g. to complete quality of life scales
• Less than 4mm of soft tissue pre-operatively
• 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
• Subjects that have received radiation therapy at the same side of the skull where the Baha Attract will be positioned
• Suitable implant position for the Baha BI300 implant system (4 mm and 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Baha Attract System

Experimental group

Description:

This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; * One implant magnet * One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)

Treatment:

Device: Baha Attract System