Clinical Trial: Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)
Brief Summary:
The rationale behind this post-market clinical follow-up investigation is to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that are candidates for Baha surgery:
- to evaluate the efficacy of the Baha Attract System in terms of hearing performance compared to the unaided situation and compared to a pre-operative test situation using the sound processor on a Baha Softband;
- to evaluate the mid- and long-term safety of the Baha Attract System.
Detailed Summary:
Sponsor: Cochlear Bone Anchored Solutions
Current Primary Outcome:
- Hearing Performance; Threshold Audiometry PTA4, Unaided Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ]The change of hearing performance with the Baha Attract System (aided) at 6 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz).
- Hearing Performance; Threshold Audiometry PTA4, Unaided Versus Baha Attract [ Time Frame: Baseline before surgery, 12 months after surgery ]The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)
- Hearing Performance; Threshold Audiometry PTA4, Unaided Versus Baha Attract [ Time Frame: Baseline before surgery, 24 months after surgery ]The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)
Original Primary Outcome:
- Hearing Performance [ Time Frame: Baseline ]To compare the hearing performance with the Baha Attract System (aided) and the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)
- Hearing Performance [ Time Frame: Week 4 ]To compare the hearing performance with the Baha Attract System (aided) and the unaided hearing performance
- Hearing Performance [ Time Frame: Month 6 ]To compare the hearing performance with the Baha Attract System (aided) and the unaided hearing performance
- Hearing Performance [ Time Frame: Month 12 ]To compare the hearing performance with the Baha Attract System (aided) and the unaided hearing performance.
- Hearing Performance [ Time Frame: Month 24 ]To compare the hearing performance with the Baha Attract System (aided) and the unaided hearing performance.
Current Secondary Outcome:
- Hearing Performance; Threshold Audiometry Individual Frequencies, Unaided Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ]
The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests:
Threshold audiometry at individual frequencies
- Adaptive Speech Recognition in Noise, Unaided Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ]The change of hearing performance with the Baha Attract System compared to the pre-operative unaided situation; Adaptive speech recognition in noise measured as signal to noise ratio
- Speech in Quiet, Unaided Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ]The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative unaided situation; Speech in quiet at 50, 65 and 80dB
- Hearing Performance; Threshold Audiometry PTA4, Sound Processor on Softband Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ]The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance, sound processor on a softband, before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)
- Hearing Performance; Threshold Audiometry Individual Frequencies, Sound Processor on Softband Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ]
The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a softband before surgery; measured as free-field hearing tests:
Threshold audiometry at individual frequencies
- Adaptive Speech Recognition in Noise, Sound Processor on Softband Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ]The change of hearing performance with the Baha Attract System compared to the pre-operative aided situation with Sound Processor on a softband; Adaptive speech recognition in noise measured as signal to noise ratio
- Speech in Quiet, Sound Processor on Softband Versus Baha Attract [ Time Frame: Baseline before surgery, 6 months after surgery ]The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative aided situation with the Sound Processor on a softband; Speech in quiet at 50, 65 and 80dB
- Health Utility Index (HUI) [ Time Frame: Baseline before surgery, 6 months after surgery ]Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Baha Attract System compared to the pre-operative unaided situation. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from unaided to aided hearing is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
- Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: Baseline before surgery, 6 months after surgery ]Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Baha Attract System from the pe-operative unaided situation. The absolute APHAB scale is between 0 and 100%, where 0% indicates no problems 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.
- Speech, Spatial and Qualities of Hearing Scale (SSQ) [ Time Frame: Baseline before surgery, 6 months after surgery ]Measuring change of speech, spatial and hearing experiences with the Baha Attract System from the pe-operative unaided situation. A scale from 0 to 10, where 0 represents "can not hear at all", and 10 "hear perfectly". The change from unaided to aided hearing is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
- Time to Perform Surgery [ Time Frame: Visit 2 (Surgery) ]Time of first incision to time of last suture
- Tissue Reduction Performed During Surgery [ Time Frame: Visit 2 (surgery) ]Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm
- Implant Stability [ Time Frame: Visit 2 (surgery) ]Implant
Original Secondary Outcome:
- Hearing performance [ Time Frame: Baseline, Week4, Month 6, Month 12, Month 24 ]
To compare the hearing performance with the Baha Attract System and the hearing performance with the same sound processor on a Baha Softband measured as
Free-field hearing tests:
- Threshold audiometry
- Adaptive speech recognition in noise
- Speech in quiet
- BC Direct thresholds
- Hearing Processor Outcome [ Time Frame: Baseline, Month 6, Month 24 ]• To compare health status and health-related quality of life and utility scores before and after use of the Baha Attract System measured with Health Utility Index.
- Hearing Processor Outcome [ Time Frame: Baseline, Month 6, Month 24 ]• To compare self-reported assessment of hearing aid outcome before and after use of the Baha Attract System measures with APHAB and SSQ scales
- Time to Perform Surgery [ Time Frame: Surgery visit ]• To collect surgical information.
- Magnetic Force [ Time Frame: Week 4, Week 6, Week 12, Month 6, Month 12, Month 24 ]• To investigate if the Sound Processor Magnet strength and magnetic force required for retention changes over time
- Safety [ Time Frame: Surgery, Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24 ]
- To collect information regarding pain, discomfort, numbness and soft tissue status.
- To monitor implant survival.
- To collect Adverse Events and device deficiencies.
Information By: Cochlear Bone Anchored Solutions
Dates:
Date Received: December 16, 2013
Date Started: June 2014
Date Completion: March 2017
Last Updated: December 9, 2016
Last Verified: December 2016
- Hearing performance [ Time Frame: Baseline, Week4, Month 6, Month 12, Month 24 ]