Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier:
NCT01822119
First received: March 19, 2013
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

The rationale behind this clinical performance investigation is to collect data regarding the usability of the Baha Attract System in patients with hearing impairment that are candidates for Baha surgery:

  • To describe the expected hearing performance with the Baha Attract in comparison to unaided hearing thresholds or a pre-test situation using a sound processor together with a softband
  • Which sound processor to select, i.e. BP100 vs BP110
  • Improve the fitting process for the sound processor
  • Selection of sound processor magnet at time of fitting and over time

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: Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System). A Multicentre, Open, Prospective Clinical Investigation. 3 Months Investigation With a 6 Months Follow-up

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 Baha Attract/sound processor (aided) with the unaided hearing performance before surgery. The following audiological tests will be performed:free field thresholds, speech recognition in noise and speech recognition in quiet

  • Hearing Performance [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery

  • Hearing performance [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery

  • Hearing performance [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery

  • Hearing performance [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
    To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery


Secondary Outcome Measures:
  • Hearing Aid Outcome [ Time Frame: Baseline and week 12, 30 ] [ Designated as safety issue: No ]
    To compare the Self-Report Assessment of Hearing Aid Outcome before and after use of Baha Attract/sound processor


Other Outcome Measures:
  • Hearing performance [ Time Frame: Baseline and week 4, 6, 12, 30 ] [ Designated as safety issue: No ]
    • To compare the hearing performance with Baha Attract/sound processor with the hearing performance with the system currently used by the subject
    • To compare the hearing performance with Baha Attract/sound processor with the hearing performance with softband/sound processor

    The following audiological tests will be performed:free field thresholds, speech recognition in noise and speech recognition in quiet


  • Time to perform surgery [ Time Frame: Visit 2 (surgery) ] [ Designated as safety issue: No ]
  • Choice of Sound Processor [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    To compare the sound processors BP100 and BP110 attached to a soft band(subject preference)

  • Feedback measurement [ Time Frame: Baseline and week 4 and 12 ] [ Designated as safety issue: No ]
    Perform feedback measurements and investigate if this changes over time. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output.

  • Magnetic force [ Time Frame: Week 4, 6, 12 and 30 ] [ Designated as safety issue: No ]
    To investigate if the magnetic force required for sound processor magnet retention will change over time

  • Safety [ Time Frame: Week 0 to 30 ] [ Designated as safety issue: Yes ]
    • Skin evaluation
    • Pain
    • Numbness
    • Removal of inner magnet
    • Device deficiency
    • Adverse events • Adverse Events

  • Tissue reduction performed during surgery [ Time Frame: Visit 2 (surgery) ] [ Designated as safety issue: No ]
  • Implant stability [ Time Frame: Visit 2 (surgery) ] [ Designated as safety issue: No ]
    Implant Stability Quotient - ISQ


Estimated Enrollment: 22
Study Start Date: March 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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:

  • Conductive hearing loss in the implanted ear. Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz <30 decibel (dB) hearing level (HL)
  • Single-sided Sensorineural Deafness (SSD). Bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 Hz <30 dB hearing level (HL) in the best ear
  • Signed informed consent

Exclusion Criteria:

  • Uncontrolled diabetes as judged by the investigator
  • Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
  • Unable to follow investigational procedures, e.g. to complete quality of life scales
  • Less than 4mm of soft tissue pre-operatively
  • Participation in another investigation with pharmaceuticals and/or device
  • Condition that may have an impact on the outcome of the investigation as judged by the investigator
  • Subjects that have received radiation therapy at the same side of the skull where the Baha Attract will be positioned
  • Suitable implant position for the Baha BI300 implant system (4 mm and 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness
  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: NCT01822119

Locations
Australia, Victoria
The HEARing CRC & HearWorks, University of Melbourne
Melbourne, Victoria, Australia, 3010
Chile
Clinica Las Condes
Santiago, Chile
Hong Kong
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Israel
Bnai Zion MedicalCenter
Haifa, Israel, 31048
Sponsors and Collaborators
Cochlear Bone Anchored Solutions
Investigators
Principal Investigator: Robert Cowan, A/Professor The HEARing CRC & HearWorks, University of Melbourne
  More Information

No publications provided

Responsible Party: Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier: NCT01822119     History of Changes
Other Study ID Numbers: CBAS5484
Study First Received: March 19, 2013
Last Updated: March 14, 2014
Health Authority: Australia: Human Research Ethics Committee
Chile: Comité de Ética Científico

Additional relevant MeSH terms:
Deafness
Hearing Loss
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 July 24, 2014