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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier:
NCT02022085
First received: December 16, 2013
Last updated: October 18, 2016
Last verified: October 2016
  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; Threshold Audiometry PTA4, Unaided Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ] [ Designated as safety issue: No ]
    The change of hearing performance with the Baha Attract System (aided) at 6 months from 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; Threshold Audiometry PTA4, Unaided Versus Baha Attract [ Time Frame: Baseline before surgery, 12 months after surgery ] [ Designated as safety issue: No ]
    The change of hearing performance with the Baha Attract System (aided) from 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; Threshold Audiometry PTA4, Unaided Versus Baha Attract [ Time Frame: Baseline before surgery, 24 months after surgery ] [ Designated as safety issue: No ]
    The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)


Secondary Outcome Measures:
  • Hearing Performance; Threshold Audiometry Individual Frequencies, Unaided Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ] [ Designated as safety issue: No ]

    The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests:

    Threshold audiometry at individual frequencies


  • Adaptive Speech Recognition in Noise, Unaided Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ] [ Designated as safety issue: No ]
    The change of hearing performance with the Baha Attract System compared to the pre-operative unaided situation; Adaptive speech recognition in noise measured as signal to noise ratio

  • Speech in Quiet, Unaided Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ] [ Designated as safety issue: No ]
    The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative unaided situation; Speech in quiet at 50, 65 and 80dB

  • Hearing Performance; Threshold Audiometry PTA4, Sound Processor on Softband Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ] [ Designated as safety issue: No ]
    The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance, sound processor on a softband, before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)

  • Hearing Performance; Threshold Audiometry Individual Frequencies, Sound Processor on Softband Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ] [ Designated as safety issue: No ]

    The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a softband before surgery; measured as free-field hearing tests:

    Threshold audiometry at individual frequencies


  • Adaptive Speech Recognition in Noise, Sound Processor on Softband Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ] [ Designated as safety issue: No ]
    The change of hearing performance with the Baha Attract System compared to the pre-operative aided situation with Sound Processor on a softband; Adaptive speech recognition in noise measured as signal to noise ratio

  • Speech in Quiet, Sound Processor on Softband Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ] [ Designated as safety issue: No ]
    The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative aided situation with the Sound Processor on a softband; Speech in quiet at 50, 65 and 80dB

  • Health Utility Index (HUI) [ Time Frame: Baseline before surgery, 6 months after surgery ] [ Designated as safety issue: No ]
    Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Baha Attract System compared to the pre-operative unaided situation. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from unaided to aided hearing is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.

  • Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: Baseline before surgery, 6 months after surgery ] [ Designated as safety issue: No ]
    Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Baha Attract System from the pe-operative unaided situation. The absolut APHAB scale is between 0 and 100%, where 0% indicates no problems and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairement.

  • Speech, Spatial and Qualities of Hearing Scale (SSQ) [ Time Frame: Baseline before surgery, 6 months after surgery ] [ Designated as safety issue: No ]
    Measuring change of speech, spatial and hearing experiences with the Baha Attract System from the pe-operative unaided situation. A scale from 0 to 10, where 0 represents "can not hear at all", and 10 "hear perfectly". The change from unaided to aided hearing is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.

  • Time to Perform Surgery [ Time Frame: Visit 2 (Surgery) ] [ Designated as safety issue: No ]
    Time of first incision to time of last suture

  • Tissue Reduction Performed During Surgery [ Time Frame: Visit 2 (surgery) ] [ Designated as safety issue: No ]
    Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm

  • Implant Stability [ Time Frame: Visit 2 (surgery) ] [ Designated as safety issue: No ]
    Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability

  • Magnetic Force [ Time Frame: 4, 6, 12 weeks, 6 months ] [ Designated as safety issue: No ]
    To investigate if the magnetic force required for sound processor magnet retention will change over time

  • Sound Processor Magnet Choice [ Time Frame: 4, 6, 12 weeks, 6 months ] [ Designated as safety issue: No ]
    To investigate how sound processor magnet choice will change over time. Six different magnetic strength could be chosen; SPM 1 had the lowest strength and SPM 6 the the highest.

  • Pain [ Time Frame: Week 6, Week 12, Month 6 ] [ Designated as safety issue: Yes ]
    Degree of pain and discomfort.

  • Numbness [ Time Frame: Day 10, Week 4, Week 6, Week 12, Month 6 ] [ Designated as safety issue: Yes ]
    Degree of numbness when tested with a pin


Enrollment: 54
Study Start Date: June 2014
Estimated Study Completion Date: March 2017
Primary Completion Date: February 2016 (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
The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Locations
United States, Washington
Dr. Doug Backhus
Seattle, Washington, United States, 98122
United States, Wisconsin
Christina Runge
Milwaukee, Wisconsin, United States, 53227
Netherlands
Dr. Myrthe Hol
Nijmegen, Netherlands
Poland
World Hearing Center Institute of Physiology and Pathology of Hearing
Kajetany, Nadarzyn, Poland, 05-830
United Kingdom
Peter Monksfield
Birmingham, United Kingdom
Kevin Green
Manchester, United Kingdom
Sponsors and Collaborators
Cochlear Bone Anchored Solutions
Investigators
Study Director: Johan Blechert, M.Sc Cochlear Bone Anchored Solutions AB
  More Information

Responsible Party: Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier: NCT02022085     History of Changes
Other Study ID Numbers: CBAS5477 
Study First Received: December 16, 2013
Results First Received: August 24, 2016
Last Updated: October 18, 2016
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 December 09, 2016