Clinical Trial: Clinical Performance of a New Implant System for Bone Conduction Hearing
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Clinical Performance of a New Implant System for Bone Conduction Hearing
Brief Summary: To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.
Detailed Summary:
Sponsor: Cochlear Bone Anchored Solutions
Current Primary Outcome:
- Hearing performance: threshold audiometry PTA4, unaided versus OSIA system at 3 months [ Time Frame: Baseline before surgery, 3 months after surgery ]The change of hearing performance with the OSIA system (aided) at 3 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).
- Speech in quiet at 65dB, unaided versus OSIA system at 3 months [ Time Frame: Baseline before surgery, 3 months after surgery ]The change of hearing performance [% correctly perceived words at 65dB SPL] with the OSIA System at 3 months compared to the pre-operative unaided situation; Speech in quiet at 65 dB SPL
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Hearing performance: threshold audiometry PTA4, unaided versus OSIA system at 12 months [ Time Frame: Baseline before surgery, 12 months after surgery ]The change of hearing performance with the OSIA system (aided) at 12 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 individual frequences, unaided versus OSIA system [ Time Frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery ]The change of hearing performance with the OSIA system (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz).
- Speech in quiet at 50, 65 and 80 dB SPL, unaided versus OSIA system [ Time Frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery ]The change of hearing performance [% correctly perceived words at 50, 65 and 80 dB SPL] with the OSIA System compared to the pre-operative unaided situation; Speech in quiet at 50, 65 and 80 dB SPL
- Adaptive Speech Recognition in Noise, unaided versus OSIA system [ Time Frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery ]The change of hearing performance with the OSIA System compared to the pre-operative unaided situation; Adaptive speech recognition in noise measured as signal to noise ratio
- Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: Baseline before surgery, 3 and 12 months after surgery ]Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the OSIA System from the pre-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.
- Health Utility Index (HUI) [ Time Frame: Baseline before surgery, 3 and 12 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 OSIA 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.
- Speech, Spatial and Qualities of Hearing Scale (SSQ) [ Time Frame: Baseline before surgery, 3 and 12 months after surgery ]Measuring change of speech, spatial and hearing experiences with the OSIA System from the pe-operative unaided situation. A scale from 0 to 10 is used, 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.
- Hearing performance: threshold audiometry PTA4, with reference device BP110 [ Time Frame: Baseline before surgery ]Hearing performance with the reference device BP110 on a softband (aided) before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz).
- Hearing performance: threshold audiometry individual frequences with reference device BP110 [ Time Frame: Baseline before surgery ]Hearing performance with the reference device BP110 on a softband (aided); measured as free-field hearing tests: Threshold audiometry (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz).
- Speech in quiet at 50, 65 and 80 dB SPL, with reference device BP110 [ Time Frame: Baseline before surgery ]Hearing performance [% correctly perceived words at 65dB SPL] with the reference device BP110 on a softband (aided); Speech in quiet at 50, 65 and 80 dB SPL
- Adaptive Speech Recognition in Noise, with reference device BP110 [ Time Frame: Baseline before surgery ]Hearing performance with the reference device BP110 on a softband (aided); Adaptive speech recognition in noise measured as signal to noise ratio
- Surgical information: time of surgery [ Time Frame: Visit 2, surgery ]Surgery time in minutes between first incision and last suture
- Surgical information: soft tissue thickness [ Time Frame: Visit 2, surgery ]Soft tissue thickness in mm
- Surgical information: soft tissue reduction [ Time Frame: Visit 2, surgery ]Same as current
Information By: Cochlear Bone Anchored Solutions
Dates:
Date Received: March 9, 2017
Date Started: March 9, 2017
Date Completion: December 2018
Last Updated: May 3, 2017
Last Verified: May 2017
