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

NCT ID: NCT01822119

Last Updated: 2017-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-02-28

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

Conditions

Deafness; Hearing Loss; Hearing Loss, Conductive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Baha Attract System

Intervention Type: DEVICE

Interventions

Baha Attract System

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cochlear Bone Anchored Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Cowan, A/Professor

Role: PRINCIPAL_INVESTIGATOR

The HEARing CRC & HearWorks, University of Melbourne

Locations

The HEARing CRC & HearWorks, University of Melbourne

Melbourne, Victoria, Australia

Clinica Las Condes

Santiago, , Chile

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Bnai Zion MedicalCenter

Haifa, , Israel

Countries

Australia; Chile; Hong Kong; Israel

References

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.

Reference Type: RESULT

PMID: 25634465 (View on PubMed)

Other Identifiers

CBAS5484

Identifier Type: -

Identifier Source: org_study_id