Clinical Trial: Evaluation of Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Audiological Outcomes and Subjective Benefits of Cochlear Baha® 5 SuperPower Sound Processor on the Baha® Attract™ System

Brief Summary: The aim of this clinical investigation is to evaluate objective and subjective hearing performance with the Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System, compared to the unaided hearing performance. Comparison of audiological test results with the same sound processor on a Baha Softband will also be performed. Short term safety parameters will be collected.

Detailed Summary:

The Cochlear Baha bone conduction hearing implant offers two alternative ways to transmit vibrations from the external sound processor to the osseointegrated implant: The Baha Connect System uses a skin-penetrating abutment and allows direct bone conduction. The Baha Attract System uses a magnetic connection through intact skin. Magnetic bone conduction hearing implants have the advantage over skin-penetrating systems of eliminating the daily cleaning of the site and are perceived as a more cosmetically appealing by some subjects. With modern sound processor technology, it is possible to obtain good sound transmission despite the soft tissue attenuation that is inherent to magnetic bone conduction hearing implants. Clinical investigations have shown that the Baha Attract System, when used in combination with existing head-worn sound processors within the Premium (e.g. BP100, Baha 4 Sound Processors) and Power (BP110 Sound processor) segments, provides good hearing outcomes in subjects with conductive and mild mixed hearing loss.

The Cochlear Baha 5 SuperPower Sound Processor is the first head-worn sound processor within the Super Power segment and has a fitting range of 65 dBHL. It is CE marked and is intended for subjects with mixed hearing loss or single-sided sensorineural deafness (SSD). It can be used with the Baha Connect and Baha Attract Systems and with a Baha Softband. When used in combination with the Baha Attract System, it will be able to compensate for a larger sensorineural component than the current Premium and Power sound processors and, hence, will allow more subjects to benefit from the Baha Attract System. The combination Baha Attract System with Baha 5 SuperPower Sound Processor is the most powerful non-skin penetrating bone conduction hearing implant solution available today.

The Baha 5 SuperPower Soun
Sponsor: Cochlear Bone Anchored Solutions

Current Primary Outcome: Change of hearing performance PTA4 from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks [ Time Frame: 12 weeks ]

Audiometry; free field thresholds. Pure tone average PTA4 [Mean of 0.5, 1, 2 and 4 kHz]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change of the self-reported assessments of hearing outcome APHAB from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks [ Time Frame: 12 weeks ]
    Abbreviated Profile of Hearing Aid Benefit (APHAB)
  • Change of the self-reported assessments of hearing outcome SSQ-12 from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks [ Time Frame: 12 weeks ]
    Speech, Spatial and Qualities of Hearing Scale (SSQ-12)
  • Change of hearing performance PTA4 from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks [ Time Frame: 4 weeks ]
    Audiometry; free field thresholds. Pure tone average PTA4 [Mean of 0.5, 1, 2 and 4 kHz]
  • Change of hearing performance free field tresholds per frequency from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks [ Time Frame: 4 weeks ]
    Audiometry; free field thresholds per frequency[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz]
  • Change of hearing performance free field tresholds per frequency from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks [ Time Frame: 12 weeks ]
    Audiometry; free field thresholds per frequency[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz]
  • Change of hearing performance free field - adaptive speech recognition in noise from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks [ Time Frame: 4 weeks ]
    Free field; - Adaptive speech recognition in noise
  • Change of hearing performance free field - adaptive speech recognition in noise from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks [ Time Frame: 12 weeks ]
    Free field; - Adaptive speech recognition in noise
  • Change of hearing performance free field - speech recognition in quiet from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks [ Time Frame: 4 weeks ]
    Free field; - Speech recognition in quiet
  • Change of hearing performance free field - speech recognition in quiet from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks [ Time Frame: 12 weeks ]
    Free field; - Speech recognition in quiet
  • Change of hearing performance PTA4 from the situation with the same sound processor on a Baha soft band at pre-operation with the Investigational device on the attract system at 4 weeks [ Time Frame: 4 weeks ]
    Audiometry; free field thresholds. Pure tone average PTA4 [Mean of 0.5, 1, 2 and 4 kHz]
  • Change of hearing performance PTA4 from the situation with the same sound processor on a Baha soft band at pre-operation with the Investigational device on the attract system at 12 weeks [ Time Frame: 12 weeks ]
    Audiometry; free field thresholds. Pure tone average PTA4 [Mean of 0.5, 1, 2 and 4 kHz]
  • Change of hearing performance free field tresholds per frequency from the situation with same sound processor on a Baha softband with the Investigational device on the attract system at 4 weeks [ Time Frame: 4 weeks ]
    Audiometry; Free field thresholds per frequency[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz]
  • Change of hearing performance free field tresholds per frequency from the same sound processor on a Baha softband with the Investigational device on the attract system at 12 weeks [ Time Frame: 12 weeks ]
    Audiometry; Free field thresholds per frequency[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz]
  • Change of hearing performance BC Direct tresholds per frequency from the situation with the sound processor on a Baha softband at pre-operation with the Investigational device on the attract system tresholds at 4 weeks [ Time Frame: 4 weeks ]
    BC Direct thresholds per frequency [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz]
  • Change of hearing performance BC Direct tresholds per frequency from the situation with the sound processor on a Baha softband at pre-operation with the Investigational device on the attract system tresholds at 12 weeks [ Time Frame: 12 weeks ]
    BC Direct thresholds per frequency [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz]
  • Same as current

    Information By: Cochlear Bone Anchored Solutions

    Dates:
    Date Received: February 17, 2016
    Date Started: April 2016
    Date Completion:
    Last Updated: January 19, 2017
    Last Verified: October 2016