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

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

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

Study Overview

• Status: Completed
• Conditions: Hearing Loss; Deafness; Hearing Loss, Conductive
• Intervention / Treatment: Device: Baha Attract System

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3010
      • The HEARing CRC & HearWorks, University of Melbourne
• Chile
  • Santiago, Chile
    • Clinica Las Condes
• Hong Kong
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong
• Israel
  • Haifa, Israel, 31048
    • Bnai Zion MedicalCenter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Device: Baha Attract System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing Performance, PTA4 at 12 Weeks	The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 12.	Baseline before surgery and 12 weeks after surgery
Hearing Performance, PTA4 at 36 Weeks	The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.	Baseline before surgery and 36 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing Performance, Individual Frequencies	The change in pure-tone thresholds in free field measured by the difference at individual frequencies from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.	Baseline before surgery and 36 weeks after surgery
Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks	The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.	Baseline before surgery and 36 weeks after surgery
Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks	The change in pure-tone thresholds in free field measured by the difference in hearing levels of individual frequencies from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.	Baseline before surgery and 36 weeks after surgery
Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks	The change in hearing performance, speech in quiet from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.	Baseline before surgery and 36 weeks after surgery
Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks	The change in hearing performance, speech in quiet from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.	Baseline before surgery and 36 weeks after surgery
Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks	The change in hearing performance, speech in noise from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.	Baseline before surgery and 36 weeks after surgery
Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks	The change in hearing performance, speech in noise from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.	Baseline before surgery and 36 weeks after surgery
Abbreviated Profile of Hearing Aid Benefit (APHAB)	Change of APHAB scoring from the unaided pre-operative situation to the aided situation with Baha Attract at 36 weeks. APHAB questionnaire is a 24-item self-assessment inventory that evaluates the benefit experienced by the patient when using hearing amplification compared to the unaided situation. APHAB produces a Global score and scores for four subscales: ease of communication (EC), reverberation (RV), background noise (BN), and aversiveness (AV). The absolute APHAB scale is between 0 and 100%, where 0% indicates no problem and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment. This scale applies to all reported scores.	Baseline before surgery and 36 weeks after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Perform Surgery		Visit 2 (surgery)
Tissue Reduction Performed During Surgery	Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm.	Visit 2 (surgery)
Implant Stability	Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability.	Visit 2 (surgery)
Choice of Sound Processor	Type of sound processors BP100 and BP110 attached to a soft band (subject preference)	Baseline
Feedback Measurement, BP100	Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. 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. A negative value of the change means less feedback.	Baseline before surgery and 12 weeks after surgery
Feedback Measurement, BP110	Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. 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. A negative value of the change means less feedback.	Baseline before surgery and 12 weeks after surgery
Magnetic Force	To investigate if the magnetic force required for sound processor magnet retention will change over time	Week 4, 6, 12 and 36
Safety; Skin Evaluation	Evaluation of the skin using the Patient and Observer Scar Assessment Scale (POSASa scale from 1 (normal skin) to 10 (worst scar imaginable).	36 weeks
Safety; Pain	Evaluation of neuropathic pain or pain in the scar the last week by asking the patients to rate their experience on a scale from 1 (no, not at all) to 10 (yes, very much).	36 weeks
Safety; Numbness	Evaluation of numbness by asking the patients if they had experienced any numbness within 2 cm from the centre of the implant magnet or within and beyond 2 cm from the centre of the implant magnet.	36 weeks

Collaborators and Investigators

• Sponsor: Cochlear Bone Anchored Solutions
• Investigators: Principal Investigator: Robert Cowan, A/Professor, The HEARing CRC & HearWorks, University of Melbourne

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: March 19, 2013
• First Submitted That Met QC Criteria: April 1, 2013
• First Posted (ESTIMATE): April 2, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 6, 2017
• Last Update Submitted That Met QC Criteria: December 12, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Conductive
• Other Study ID Numbers: CBAS5484