Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)

Completed · Not applicable

Conditions studied: Deafness, Hearing Loss, Hearing Loss, Conductive

In brief

The rationale behind this post-market clinical follow-up investigation is to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that are candidates for Baha surgery: * to evaluate the efficacy of the Baha Attract System in terms of hearing performance compared to the unaided situation and compared to a pre-operative test situation using the sound processor on a Baha Softband; * to evaluate the mid- and long-term safety of the Baha Attract System.

Key facts

Study ID

NCT02022085

Run by

Cochlear Bone Anchored Solutions

People needed

54

Starts

2014-06-01

Expected to finish

2017-11-01

Last updated by the study team

2018-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult subject, i.e. ≥ 18 years of age
• Conductive or mixed hearing loss in the ear to be implanted:
• Bone conduction thresholds with a pure tone average PTA4 of < 30 dB hearing level (mean of 500, 1000, 2000 and 4000 Hz).
• OR
• Single-sided sensorineural deafness (SSD):
• European sites: Bone conduction thresholds with a pure tone average PTA4 of < 30dB hearing level (mean of 500, 1000, 2000 and 4000 Hz) in the good ear.
• US sites: Air conduction thresholds with a pure tone average PTA4 of 20 dB hearing level (mean of 500, 1000, 2000 and 3000 Hz) in the good ear OR Subject is indicated for an AC CROS but-for some reason-cannot or will not use an AC CROS.
• No previous bone conduction implant on the side of the skull to be implanted. Signed informed consent.

You may not qualify if…

• Subjects that are scheduled for simultaneous bilateral implant surgery. The investigation is limited to subjects with unilateral use of the Baha Attract System (however, bilateral hearing loss is not an exclusion criterion).
• Suitable implant position for the BI300 Implant (4 mm or 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness.
• Less than 3 mm soft tissue thickness at the planned implant site. Subjects that have received radiation therapy at the same side of the skull where the Baha Attract System will be positioned.
• Condition that could jeopardise osseointegration and/or wound healing as judged by the investigator (e.g. osteoporosis, psoriasis, use of corticosteroids).
• Uncontrolled diabetes as judged by the investigator. Condition that may have an impact on the outcome of the investigation as judged by the investigator.
• Unable to follow investigational procedures (e.g. to complete quality of life scales).
• Participation in another investigation with pharmaceuticals and/or medical device.

Where it is running

• Dr. Doug Backhus — Seattle, Washington, United States
• Christina Runge — Milwaukee, Wisconsin, United States
• Dr. Myrthe Hol — Nijmegen, Netherlands
• World Hearing Center Institute of Physiology and Pathology of Hearing — Kajetany, Nadarzyn, Poland
• Peter Monksfield — Birmingham, United Kingdom
• Kevin Green — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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