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

Hearing Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822119
• Other study ID #: CBAS5484
• Status: Completed
• Phase: N/A
• First received: March 19, 2013
• Last updated: February 24, 2015
• Start date: March 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2015
• Source: Cochlear Bone Anchored Solutions
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeChile: Comité de Ética Científico
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Conductive

Intervention

Device:
• Baha Attract System

Locations

Country	Name	City	State
Australia	The HEARing CRC & HearWorks, University of Melbourne	Melbourne	Victoria
Chile	Clinica Las Condes	Santiago
Hong Kong	The Chinese University of Hong Kong	Hong Kong
Israel	Bnai Zion MedicalCenter	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear Bone Anchored Solutions

Countries where clinical trial is conducted

Australia,  Chile,  Hong Kong,  Israel, 

References & Publications (1)

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. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hearing performance	To compare the hearing performance with Baha Attract/sound processor with the hearing performance with the system currently used by the subject; To compare the hearing performance with Baha Attract/sound processor with the hearing performance with softband/sound processor; The following audiological tests will be performed:free field thresholds, speech recognition in noise and speech recognition in quiet	Baseline and week 4, 6, 12, 30	No
Other	Time to perform surgery		Visit 2 (surgery)	No
Other	Choice of Sound Processor	To compare the sound processors BP100 and BP110 attached to a soft band(subject preference)	Baseline	No
Other	Feedback measurement	Perform feedback measurements and investigate if this changes over time. 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.	Baseline and week 4 and 12	No
Other	Magnetic force	To investigate if the magnetic force required for sound processor magnet retention will change over time	Week 4, 6, 12 and 30	No
Other	Safety	Skin evaluation; Pain; Numbness; Removal of inner magnet; Device deficiency; Adverse events • Adverse Events	Week 0 to 30	Yes
Other	Tissue reduction performed during surgery		Visit 2 (surgery)	No
Other	Implant stability	Implant Stability Quotient - ISQ	Visit 2 (surgery)	No
Primary	Hearing performance	To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery. The following audiological tests will be performed:free field thresholds, speech recognition in noise and speech recognition in quiet	Baseline	No
Primary	Hearing Performance	To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery	Week 4	No
Primary	Hearing performance	To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery	Week 6	No
Primary	Hearing performance	To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery	Week 12	No
Primary	Hearing performance	To compare the hearing performance with Baha Attract/sound processor (aided) with the unaided hearing performance before surgery	Week 30	No
Secondary	Hearing Aid Outcome	To compare the Self-Report Assessment of Hearing Aid Outcome before and after use of Baha Attract/sound processor	Baseline and week 12, 30	No