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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Cochlear Bone Anchored Solutions
Sponsor:
Information provided by (Responsible Party):
Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier:
NCT02022085
First received: December 16, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention
Deafness
Hearing Loss
Hearing Loss, Conductive
Device: Baha Attract System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)

Resource links provided by NLM:


Further study details as provided by Cochlear Bone Anchored Solutions:

Primary Outcome Measures:
  • Hearing Performance [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    To compare the hearing performance with the Baha Attract System (aided) and the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)

  • Hearing Performance [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    To compare the hearing performance with the Baha Attract System (aided) and the unaided hearing performance

  • Hearing Performance [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    To compare the hearing performance with the Baha Attract System (aided) and the unaided hearing performance

  • Hearing Performance [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    To compare the hearing performance with the Baha Attract System (aided) and the unaided hearing performance.

  • Hearing Performance [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    To compare the hearing performance with the Baha Attract System (aided) and the unaided hearing performance.


Secondary Outcome Measures:
  • Hearing performance [ Time Frame: Baseline, Week4, Month 6, Month 12, Month 24 ] [ Designated as safety issue: No ]

    To compare the hearing performance with the Baha Attract System and the hearing performance with the same sound processor on a Baha Softband measured as

    • Free-field hearing tests:

      • Threshold audiometry
      • Adaptive speech recognition in noise
      • Speech in quiet
    • BC Direct thresholds

  • Hearing Processor Outcome [ Time Frame: Baseline, Month 6, Month 24 ] [ Designated as safety issue: No ]
    • To compare health status and health-related quality of life and utility scores before and after use of the Baha Attract System measured with Health Utility Index.

  • Hearing Processor Outcome [ Time Frame: Baseline, Month 6, Month 24 ] [ Designated as safety issue: No ]
    • To compare self-reported assessment of hearing aid outcome before and after use of the Baha Attract System measures with APHAB and SSQ scales

  • Time to perform surgery [ Time Frame: Surgery visit ] [ Designated as safety issue: No ]
    • To collect surgical information.

  • Magnetic Force [ Time Frame: Week 4, Week 6, Week 12, Month 6, Month 12, Month 24 ] [ Designated as safety issue: No ]
    • To investigate if the Sound Processor Magnet strength and magnetic force required for retention changes over time

  • Safety [ Time Frame: Surgery, Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24 ] [ Designated as safety issue: Yes ]
    • To collect information regarding pain, discomfort, numbness and soft tissue status.
    • To monitor implant survival.
    • To collect Adverse Events and device deficiencies.


Estimated Enrollment: 52
Study Start Date: April 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baha Attract System

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)
Device: Baha Attract System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022085

Contacts
Contact: Andrea Sandberg, M.Sc (+46) 766498653 asandberg@cochlear.com
Contact: Johan I Blechert, M.Sc +46 31 792 46 32 jblechert@cochlear.com

Locations
United States, Washington
Dr. Doug Backhus Not yet recruiting
Seattle, Washington, United States
Contact: Doug Dr Backhus, Douglas.Backous@swedish.org         
Principal Investigator: Doug Dr Backhus         
United States, Wisconsin
Christina Runge Recruiting
Milwaukee, Wisconsin, United States
Contact: Christina Runge, Phd aud         
Principal Investigator: Christina Runge, PhD         
Netherlands
Dr. Myrthe Hol Recruiting
Nijmegen, Netherlands
Contact: Myrthe Hool         
Principal Investigator: Myrthe Dr. M.K.S Hol, Md, PhD         
United Kingdom
Peter Monksfield Not yet recruiting
Birmingham, United Kingdom
Contact: Peter Mr Monksfield         
Principal Investigator: Peter Mr Monksfield         
Kevin Green Recruiting
Manchester, United Kingdom
Contact: Kevin Mr Green         
Principal Investigator: Kevin Dr Green         
Sponsors and Collaborators
Cochlear Bone Anchored Solutions
  More Information

No publications provided

Responsible Party: Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier: NCT02022085     History of Changes
Other Study ID Numbers: CBAS5477
Study First Received: December 16, 2013
Last Updated: May 27, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United States: Food and Drug Administration
United Kingdom: National Institute for Health Research

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Conductive
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014