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

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ClinicalTrials.gov Identifier: NCT01822119
Recruitment Status : Completed
First Posted : April 2, 2013
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Cochlear Bone Anchored Solutions

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Deafness
Hearing Loss
Hearing Loss, Conductive
Intervention: Device: Baha Attract System

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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)

Baha Attract System


Participant Flow:   Overall Study
    Baha Attract System
STARTED   27 
COMPLETED   27 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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)

Baha Attract System


Baseline Measures
   Baha Attract System 
Overall Participants Analyzed 
[Units: Participants]
 27 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.7  (13.8) 
Gender 
[Units: Participants]
Count of Participants
 
Female      15  55.6% 
Male      12  44.4% 
Region of Enrollment 
[Units: Participants]
 
Hong Kong   8 
Israel   6 
Australia   8 
Chile   5 
Type of hearing loss 
[Units: Participants]
 
Conductive hearing loss   17 
Single-sided sensorineural deafness   10 


  Outcome Measures

1.  Primary:   Hearing Performance, PTA4 at 12 Weeks   [ Time Frame: Baseline before surgery and 12 weeks after surgery ]

2.  Primary:   Hearing Performance, PTA4 at 36 Weeks   [ Time Frame: Baseline before surgery and 36 weeks after surgery ]

3.  Secondary:   Hearing Performance, Individual Frequencies   [ Time Frame: Baseline before surgery and 36 weeks after surgery ]

4.  Secondary:   Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks   [ Time Frame: Baseline before surgery and 36 weeks after surgery ]

5.  Secondary:   Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks   [ Time Frame: Baseline before surgery and 36 weeks after surgery ]

6.  Secondary:   Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks   [ Time Frame: Baseline before surgery and 36 weeks after surgery ]

7.  Secondary:   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 ]

8.  Secondary:   Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks   [ Time Frame: Baseline before surgery and 36 weeks after surgery ]

9.  Secondary:   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 ]

10.  Secondary:   Abbreviated Profile of Hearing Aid Benefit (APHAB)   [ Time Frame: Baseline before surgery and 36 weeks after surgery ]

11.  Other Pre-specified:   Time to Perform Surgery   [ Time Frame: Visit 2 (surgery) ]

12.  Other Pre-specified:   Tissue Reduction Performed During Surgery   [ Time Frame: Visit 2 (surgery) ]

13.  Other Pre-specified:   Implant Stability   [ Time Frame: Visit 2 (surgery) ]

14.  Other Pre-specified:   Choice of Sound Processor   [ Time Frame: Baseline ]

15.  Other Pre-specified:   Feedback Measurement, BP100   [ Time Frame: Baseline before surgery and 12 weeks after surgery ]

16.  Other Pre-specified:   Feedback Measurement, BP110   [ Time Frame: Baseline before surgery and 12 weeks after surgery ]

17.  Other Pre-specified:   Magnetic Force   [ Time Frame: Week 4, 6, 12 and 36 ]

18.  Other Pre-specified:   Safety; Skin Evaluation   [ Time Frame: 36 weeks ]

19.  Other Pre-specified:   Safety; Pain   [ Time Frame: 36 weeks ]

20.  Other Pre-specified:   Safety; Numbness   [ Time Frame: 36 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Professor Robert Cowan
Organization: The HEARing CRC & Hearworks, Audiology Hearing and Speech Science, Melbourne, Australia
phone: +61 3 9035 5346
e-mail: r.cowan@unimelb.edu.au


Publications of Results:

Responsible Party: Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier: NCT01822119     History of Changes
Other Study ID Numbers: CBAS5484
First Submitted: March 19, 2013
First Posted: April 2, 2013
Results First Submitted: August 24, 2016
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017