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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: December 12, 2016
Last verified: December 2016
  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: 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, PTA4 at 12 Weeks [ Time Frame: Baseline before surgery and 12 weeks after surgery ]
    The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 12.

  • Hearing Performance, PTA4 at 36 Weeks [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
    The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.


Secondary Outcome Measures:
  • Hearing Performance, Individual Frequencies [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
    The change in pure-tone thresholds in free field measured by the difference at individual frequencies from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.

  • Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
    The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.

  • Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
    The change in pure-tone thresholds in free field measured by the difference in hearing levels of individual frequencies from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.

  • Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
    The change in hearing performance, speech in quiet from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.

  • Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
    The change in hearing performance, speech in quiet from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.

  • Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
    The change in hearing performance, speech in noise from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.

  • Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
    The change in hearing performance, speech in noise from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.

  • Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: Baseline before surgery and 36 weeks after surgery ]
    Change of APHAB scoring from the unaided pre-operative situation to the aided situation with Baha Attract at 36 weeks. APHAB questionnaire is a 24-item self-assessment inventory that evaluates the benefit experienced by the patient when using hearing amplification compared to the unaided situation. APHAB produces a Global score and scores for four subscales: ease of communication (EC), reverberation (RV), background noise (BN), and aversiveness (AV). The absolute APHAB scale is between 0 and 100%, where 0% indicates no problem 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. This scale applies to all reported scores.


Other Outcome Measures:
  • Time to Perform Surgery [ Time Frame: Visit 2 (surgery) ]
  • 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 Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability.

  • Choice of Sound Processor [ Time Frame: Baseline ]
    Type of sound processors BP100 and BP110 attached to a soft band (subject preference)

  • Feedback Measurement, BP100 [ Time Frame: Baseline before surgery and 12 weeks after surgery ]
    Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. 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. A negative value of the change means less feedback.

  • Feedback Measurement, BP110 [ Time Frame: Baseline before surgery and 12 weeks after surgery ]
    Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. 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. A negative value of the change means less feedback.

  • Magnetic Force [ Time Frame: Week 4, 6, 12 and 36 ]
    To investigate if the magnetic force required for sound processor magnet retention will change over time

  • Safety; Skin Evaluation [ Time Frame: 36 weeks ]
    Evaluation of the skin using the Patient and Observer Scar Assessment Scale (POSASa scale from 1 (normal skin) to 10 (worst scar imaginable).

  • Safety; Pain [ Time Frame: 36 weeks ]
    Evaluation of neuropathic pain or pain in the scar the last week by asking the patients to rate their experience on a scale from 1 (no, not at all) to 10 (yes, very much).

  • Safety; Numbness [ Time Frame: 36 weeks ]
    Evaluation of numbness by asking the patients if they had experienced any numbness within 2 cm from the centre of the implant magnet or within and beyond 2 cm from the centre of the implant magnet.


Enrollment: 27
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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Publications:
Responsible Party: Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier: NCT01822119     History of Changes
Other Study ID Numbers: CBAS5484 
Study First Received: March 19, 2013
Results First Received: August 24, 2016
Last Updated: December 12, 2016

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 February 17, 2017