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

Not Applicable

Completed

• Conditions: Deafness; Hearing Loss, Conductive; Hearing Loss
• Interventions: Device: Baha Attract System

• Registration Number: NCT01822119
• Lead Sponsor: Cochlear Bone Anchored Solutions

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-04-01
• Study First Posted: 2013-04-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Results First Submitted: 2016-08-24
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-12
• Last Update Submitted: 2016-12-12
• Results First Posted: 2017-02-06
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Baha Attract System	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)

Primary Outcome Measures

Name	Time	Method
Hearing Performance, PTA4 at 12 Weeks	Baseline before surgery and 12 weeks after surgery	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.
Hearing Performance, PTA4 at 36 Weeks	Baseline before surgery and 36 weeks after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks	Baseline before surgery and 36 weeks after surgery	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.
Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks	Baseline before surgery and 36 weeks after surgery	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.
Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks	Baseline before surgery and 36 weeks after surgery	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.
Hearing Performance, Individual Frequencies	Baseline before surgery and 36 weeks after surgery	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.
Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks	Baseline before surgery and 36 weeks after surgery	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.
Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks	Baseline before surgery and 36 weeks after surgery	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.
Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks	Baseline before surgery and 36 weeks after surgery	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.
Abbreviated Profile of Hearing Aid Benefit (APHAB)	Baseline before surgery and 36 weeks after surgery	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.

Trial Locations

Locations (4)

Clinica Las Condes; 🇨🇱 Santiago, Chile

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong

Bnai Zion MedicalCenter; 🇮🇱 Haifa, Israel

The HEARing CRC & HearWorks, University of Melbourne; 🇦🇺 Melbourne, Victoria, Australia