Clinical trial NCT01822119: 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
Overall status: COMPLETED
Phase: NA
Conditions: Deafness
Hearing Loss
Hearing Loss, Conductive
Lead sponsor: Cochlear Bone Anchored Solutions
Sponsor class: INDUSTRY
First posted: 2013-04-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Hearing Performance, PTA4 at 12 Weeks
timeFrame: Baseline before surgery and 12 weeks after surgery
measure: Hearing Performance, PTA4 at 36 Weeks
timeFrame: Baseline before surgery and 36 weeks after surgery
Secondary outcomes:
measure: Hearing Performance, Individual Frequencies
timeFrame: Baseline before surgery and 36 weeks after surgery
measure: Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks
timeFrame: Baseline before surgery and 36 weeks after surgery
measure: Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks
timeFrame: Baseline before surgery and 36 weeks after surgery
measure: Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks
timeFrame: Baseline before surgery and 36 weeks after surgery
measure: Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
timeFrame: Baseline before surgery and 36 weeks after surgery
measure: Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks
timeFrame: Baseline before surgery and 36 weeks after surgery
measure: Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks
timeFrame: Baseline before surgery and 36 weeks after surgery
measure: Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: Baseline before surgery and 36 weeks after surgery
Other outcomes:
measure: Time to Perform Surgery
timeFrame: Visit 2 (surgery)
measure: Tissue Reduction Performed During Surgery
timeFrame: Visit 2 (surgery)
measure: Implant Stability
timeFrame: Visit 2 (surgery)
measure: Choice of Sound Processor
timeFrame: Baseline
measure: Feedback Measurement, BP100
timeFrame: Baseline before surgery and 12 weeks after surgery
measure: Feedback Measurement, BP110
timeFrame: Baseline before surgery and 12 weeks after surgery
measure: Magnetic Force
timeFrame: Week 4, 6, 12 and 36
measure: Safety; Skin Evaluation
timeFrame: 36 weeks
measure: Safety; Pain
timeFrame: 36 weeks
measure: Safety; Numbness
timeFrame: 36 weeks
Locations:
city: Melbourne
country: Australia
facility: The HEARing CRC & HearWorks, University of Melbourne
state: Victoria
city: Santiago
country: Chile
facility: Clinica Las Condes
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
city: Haifa
country: Israel
facility: Bnai Zion MedicalCenter
Study officials:
affiliation: The HEARing CRC & HearWorks, University of Melbourne
name: Robert Cowan, A/Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.