Back to resultsClinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)
Primary Purpose
Deafness, Hearing Loss, Hearing Loss, Conductive
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Baha Attract System
Sponsored by
About this trial
This is an interventional treatment trial for Deafness
Eligibility 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
Sites / Locations
- The HEARing CRC & HearWorks, University of Melbourne
- Clinica Las Condes
- The Chinese University of Hong Kong
- Bnai Zion MedicalCenter
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Baha Attract System
Arm Description
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)
Outcomes
Primary Outcome Measures
Hearing Performance, PTA4 at 12 Weeks
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
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
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
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
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
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
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
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
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)
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.
Full Information
NCT ID
NCT01822119
First Posted
March 19, 2013
Last Updated
December 12, 2016
Sponsor
Cochlear Bone Anchored Solutions
1. Study Identification
Unique Protocol Identification Number
NCT01822119
Brief Title
Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear Bone Anchored Solutions
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness, Hearing Loss, Hearing Loss, Conductive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Baha Attract System
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Baha Attract System
Primary Outcome Measure Information:
Title
Hearing Performance, PTA4 at 12 Weeks
Description
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.
Time Frame
Baseline before surgery and 12 weeks after surgery
Title
Hearing Performance, PTA4 at 36 Weeks
Description
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.
Time Frame
Baseline before surgery and 36 weeks after surgery
Secondary Outcome Measure Information:
Title
Hearing Performance, Individual Frequencies
Description
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.
Time Frame
Baseline before surgery and 36 weeks after surgery
Title
Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks
Description
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.
Time Frame
Baseline before surgery and 36 weeks after surgery
Title
Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks
Description
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.
Time Frame
Baseline before surgery and 36 weeks after surgery
Title
Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks
Description
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.
Time Frame
Baseline before surgery and 36 weeks after surgery
Title
Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
Description
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.
Time Frame
Baseline before surgery and 36 weeks after surgery
Title
Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks
Description
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.
Time Frame
Baseline before surgery and 36 weeks after surgery
Title
Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
Description
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.
Time Frame
Baseline before surgery and 36 weeks after surgery
Title
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Description
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.
Time Frame
Baseline before surgery and 36 weeks after surgery
Other Pre-specified Outcome Measures:
Title
Time to Perform Surgery
Time Frame
Visit 2 (surgery)
Title
Tissue Reduction Performed During Surgery
Description
Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm.
Time Frame
Visit 2 (surgery)
Title
Implant Stability
Description
Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability.
Time Frame
Visit 2 (surgery)
Title
Choice of Sound Processor
Description
Type of sound processors BP100 and BP110 attached to a soft band (subject preference)
Time Frame
Baseline
Title
Feedback Measurement, BP100
Description
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.
Time Frame
Baseline before surgery and 12 weeks after surgery
Title
Feedback Measurement, BP110
Description
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.
Time Frame
Baseline before surgery and 12 weeks after surgery
Title
Magnetic Force
Description
To investigate if the magnetic force required for sound processor magnet retention will change over time
Time Frame
Week 4, 6, 12 and 36
Title
Safety; Skin Evaluation
Description
Evaluation of the skin using the Patient and Observer Scar Assessment Scale (POSASa scale from 1 (normal skin) to 10 (worst scar imaginable).
Time Frame
36 weeks
Title
Safety; Pain
Description
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).
Time Frame
36 weeks
Title
Safety; Numbness
Description
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.
Time Frame
36 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Cowan, A/Professor
Organizational Affiliation
The HEARing CRC & HearWorks, University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
The HEARing CRC & HearWorks, University of Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3010
Country
Australia
Facility Name
Clinica Las Condes
City
Santiago
Country
Chile
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
Bnai Zion MedicalCenter
City
Haifa
ZIP/Postal Code
31048
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
25634465
Citation
Briggs R, Van Hasselt A, Luntz M, Goycoolea M, Wigren S, Weber P, Smeds H, Flynn M, Cowan R. Clinical performance of a new magnetic bone conduction hearing implant system: results from a prospective, multicenter, clinical investigation. Otol Neurotol. 2015 Jun;36(5):834-41. doi: 10.1097/MAO.0000000000000712.
Results Reference
result
Learn more about this trial
Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)
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