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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01822119




Registration number
NCT01822119
Ethics application status
Date submitted
19/03/2013
Date registered
2/04/2013
Date last updated
6/02/2017

Titles & IDs
Public title
Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)
Scientific 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
Secondary ID [1] 0 0
CBAS5484
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deafness 0 0
Hearing Loss 0 0
Hearing Loss, Conductive 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Baha Attract System

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)


Treatment: Devices: Baha Attract System
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hearing Performance, PTA4 at 12 Weeks
Timepoint [1] 0 0
Baseline before surgery and 12 weeks after surgery
Primary outcome [2] 0 0
Hearing Performance, PTA4 at 36 Weeks
Timepoint [2] 0 0
Baseline before surgery and 36 weeks after surgery
Secondary outcome [1] 0 0
Hearing Performance, Individual Frequencies
Timepoint [1] 0 0
Baseline before surgery and 36 weeks after surgery
Secondary outcome [2] 0 0
Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks
Timepoint [2] 0 0
Baseline before surgery and 36 weeks after surgery
Secondary outcome [3] 0 0
Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks
Timepoint [3] 0 0
Baseline before surgery and 36 weeks after surgery
Secondary outcome [4] 0 0
Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks
Timepoint [4] 0 0
Baseline before surgery and 36 weeks after surgery
Secondary outcome [5] 0 0
Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
Timepoint [5] 0 0
Baseline before surgery and 36 weeks after surgery
Secondary outcome [6] 0 0
Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks
Timepoint [6] 0 0
Baseline before surgery and 36 weeks after surgery
Secondary outcome [7] 0 0
Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
Timepoint [7] 0 0
Baseline before surgery and 36 weeks after surgery
Secondary outcome [8] 0 0
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Timepoint [8] 0 0
Baseline before surgery and 36 weeks after surgery

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2014
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The HEARing CRC & HearWorks, University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Chile
State/province [1] 0 0
Santiago
Country [2] 0 0
Hong Kong
State/province [2] 0 0
Hong Kong
Country [3] 0 0
Israel
State/province [3] 0 0
Haifa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cochlear Bone Anchored Solutions
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT01822119
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Cowan, A/Professor
Address 0 0
The HEARing CRC & HearWorks, University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01822119