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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary:

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.

Detailed Summary:
Sponsor: Cochlear Bone Anchored Solutions

Current Primary Outcome:

  • Hearing Performance; Threshold Audiometry PTA4, Unaided Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ]
    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 ]
    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 ]
    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)


Original Primary Outcome:

  • Hearing Performance [ Time Frame: Baseline ]
    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 ]
    To compare the hearing performance with the Baha Attract System (aided) and the unaided hearing performance
  • Hearing Performance [ Time Frame: Month 6 ]
    To compare the hearing performance with the Baha Attract System (aided) and the unaided hearing performance
  • Hearing Performance [ Time Frame: Month 12 ]
    To compare the hearing performance with the Baha Attract System (aided) and the unaided hearing performance.
  • Hearing Performance [ Time Frame: Month 24 ]
    To compare the hearing performance with the Baha Attract System (aided) and the unaided hearing performance.


Current Secondary Outcome:

  • Hearing Performance; Threshold Audiometry Individual Frequencies, Unaided Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ]

    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 ]
    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 ]
    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 ]
    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 ]

    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 ]
    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 ]
    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 ]
    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 ]
    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 absolute 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 impairment.
  • Speech, Spatial and Qualities of Hearing Scale (SSQ) [ Time Frame: Baseline before surgery, 6 months after surgery ]
    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) ]
    Time of first incision to time of last suture
  • Tissue Reduction Performed During Surgery [ Time Frame: Visit 2 (surgery) ]
    Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm
  • Implant Stability [ Time Frame: Visit 2 (surgery) ]
    Implant

    Original Secondary Outcome:

    • Hearing performance [ Time Frame: Baseline, Week4, Month 6, Month 12, Month 24 ]

      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 ]
      • 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 ]
      • 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 ]
      • To collect surgical information.
    • Magnetic Force [ Time Frame: Week 4, Week 6, Week 12, Month 6, Month 12, Month 24 ]
      • 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 ]
      • To collect information regarding pain, discomfort, numbness and soft tissue status.
      • To monitor implant survival.
      • To collect Adverse Events and device deficiencies.


    Information By: Cochlear Bone Anchored Solutions

    Dates:
    Date Received: December 16, 2013
    Date Started: June 2014
    Date Completion: March 2017
    Last Updated: December 9, 2016
    Last Verified: December 2016