Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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)
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
NA
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
NA
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Briggs R, Van Hasselt A, Luntz M, Goycoolea M, Wig... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT01822119