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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04041700
Registration number
NCT04041700
Ethics application status
Date submitted
30/07/2019
Date registered
1/08/2019
Titles & IDs
Public title
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
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Scientific title
A Prospective, Multicentre, Open Clinical Investigation Evaluating Clinical Performance, Safety and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System (OSI) in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness
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Secondary ID [1]
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CBAS5751
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hearing Loss
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Condition category
Condition code
Ear
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Deafness
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Osia 2 system
Experimental: Osia 2 system -
Treatment: Devices: Osia 2 system
System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds
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Assessment method [1]
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Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)
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Timepoint [1]
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Baseline before surgery, 3 months after surgery
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Primary outcome [2]
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Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise
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Assessment method [2]
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Speech-to-noise ratio, 50% speech understanding
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Timepoint [2]
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Baseline before surgery, 3 months after surgery
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Secondary outcome [1]
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Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds
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Assessment method [1]
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Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)
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Timepoint [1]
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Baseline before surgery, 4 weeks and 6 months after surgery
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Secondary outcome [2]
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Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise
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Assessment method [2]
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Speech-to-noise ratio, 50% speech understanding
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Timepoint [2]
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Baseline before surgery, 4 weeks and 6 months after surgery
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Secondary outcome [3]
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Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds
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Assessment method [3]
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Free-field \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz\]
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Timepoint [3]
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Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
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Secondary outcome [4]
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Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet
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Assessment method [4]
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% correctly perceived words at 50dB, 65dB and 80dB SPL
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Timepoint [4]
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Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
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Secondary outcome [5]
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Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
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Assessment method [5]
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Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Osia 2 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 impairment, a negative value an improvement.
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Timepoint [5]
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Baseline before surgery, 3 months and 6 months after surgery
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Secondary outcome [6]
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Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire
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Assessment method [6]
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Measuring change of speech, spatial and hearing experiences with the Osia 2 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.
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Timepoint [6]
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Baseline before surgery, 3 months and 6 months after surgery
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Secondary outcome [7]
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Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire
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Assessment method [7]
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Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Osia 2 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.
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Timepoint [7]
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Baseline before surgery, 3 months and 6 months after surgery
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Secondary outcome [8]
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Surgical Information: Soft Tissue Thickness
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Assessment method [8]
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Measured in mm
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Timepoint [8]
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Baseline before surgery or at surgery
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Secondary outcome [9]
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Surgical Information: Surgery Time
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Assessment method [9]
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Time in minutes between first incision to last suture
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Timepoint [9]
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At surgery
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Secondary outcome [10]
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Surgical Information: Bone Polishing/Removal at the Actuator Site
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Assessment method [10]
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Yes/No
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Timepoint [10]
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At surgery
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Secondary outcome [11]
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Surgical Information: BI300 Implant Length
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Assessment method [11]
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3 mm/4 mm
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Timepoint [11]
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At surgery
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Secondary outcome [12]
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Surgical Information: Location of BI300 Implant
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Assessment method [12]
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Measured in mm between the ear canal and the center of the actuator
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Timepoint [12]
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At surgery
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Secondary outcome [13]
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Surgical Information: Type of Anesthesia
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Assessment method [13]
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General/local
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Timepoint [13]
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At surgery
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Secondary outcome [14]
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Surgical Information: Soft Tissue Reduction
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Assessment method [14]
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Yes/No
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Timepoint [14]
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At surgery
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Secondary outcome [15]
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Surgical Information: Surgical Incision Type
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Assessment method [15]
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Examples: C-shaped/S-shaped/straight
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Timepoint [15]
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At surgery
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Secondary outcome [16]
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Surgical Information: Location of the Surgical Incision in Relation to the Actuator
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Assessment method [16]
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Anterior/posterior
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Timepoint [16]
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At surgery
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Secondary outcome [17]
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Surgical Information: Estimated Length of the Surgical Incision
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Assessment method [17]
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Measured in mm
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Timepoint [17]
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At surgery
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Secondary outcome [18]
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Surgical Information: Placement of the Coil
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Assessment method [18]
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Periosteal pocket (under periosteal)/on top of periosteum/on top of muscle)
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Timepoint [18]
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At surgery
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Secondary outcome [19]
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Usability Information: Magnet Choice
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Assessment method [19]
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Magnet strength ranging from 1 to 4 where 1 is the weakest and 4 the strongest. A magnet allows the external sound processor to be placed in the correct position over the implanted system including an internal magnet.
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Timepoint [19]
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At 4 weeks, 6 weeks, 3 months and 6 months after surgery
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Secondary outcome [20]
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Usability Information: Sound Processor Retention
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Assessment method [20]
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Assessed via a Visual Analog Scale 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention
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Timepoint [20]
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At 4 weeks, 6 weeks, 3 months and 6 months after surgery
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Secondary outcome [21]
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Usability Information: Sound Processor Wearing Comfort
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Assessment method [21]
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Assessed via a Visual Analog Scale 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort
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Timepoint [21]
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At 4 weeks, 6 weeks, 3 months and 6 months after surgery
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Secondary outcome [22]
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Usability Information: Use of SoftWear Pad
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Assessment method [22]
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Yes/No
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Timepoint [22]
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At 6 weeks, 3 months and 6 months after surgery
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Secondary outcome [23]
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Usability Information: Daily Use of Sound Processor
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Assessment method [23]
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Average hours of daily use
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Timepoint [23]
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At 6 weeks, 3 months and 6 months after surgery
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Secondary outcome [24]
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Usability Information: Daily Streaming Time of Sound Processor
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Assessment method [24]
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Average hours of daily streaming
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Timepoint [24]
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At 6 weeks, 3 months and 6 months after surgery
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Secondary outcome [25]
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Usability Information: Battery Lifetime of Sound Processor
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Assessment method [25]
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Average hours of battery lifetime
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Timepoint [25]
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At 6 weeks, 3 months and 6 months after surgery
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Secondary outcome [26]
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Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds
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Assessment method [26]
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Free-field \[Pure Tone Average (PTA) 4, Mean of 0.5, 1, 2 and 4 kHz\].
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Timepoint [26]
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Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
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Secondary outcome [27]
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Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds
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Assessment method [27]
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Free-field \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz\].
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Timepoint [27]
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Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
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Secondary outcome [28]
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Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Adaptive Speech Recognition in Noise
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Assessment method [28]
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Signal-to-noise ratio, 50% speech understanding
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Timepoint [28]
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Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
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Secondary outcome [29]
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Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet
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Assessment method [29]
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% correctly perceived words at 50dB, 65dB and 80dB SPL
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Timepoint [29]
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Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
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Secondary outcome [30]
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Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct
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Assessment method [30]
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BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz)
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Timepoint [30]
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Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
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Eligibility
Key inclusion criteria
* Subject with conductive hearing loss or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of = 55 dB sensorineural hearing loss.
OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 (mean of 0.5, 1, 2 and 3 kHz) of = 20 dB sensorineural hearing loss in the good ear OR subject who is indicated for an (Air Conduction-Contralateral Routing of Signal (AC CROS) but-for some reason-cannot or will not use an AC CROS.
* Adult subjects (18 years or older).
* Previous experience from amplified sound through properly fitted amplification (for example but not limited to Hearing aid, Contralateral Routing of Signal (CROS) device, Bone conduction hearing device on softband).
* Candidate is a fluent speaker in the language used to assess speech perception performance.
* Willing and able to provide written informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Uncontrolled diabetes as judged by the investigator.
* Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.
* Insufficient bone quality and quantity to support successful implant placement.
* Previous surgery and/or implantation with any bone conduction/active device on the side to be implanted, which may jeopardise the implantation and use of the Osia 2 system, as judged by the investigator.
* Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.
* Unable to follow investigational procedures, e.g. to complete quality of life scales, or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
* Condition with a likely negative progression and/or with expected relapses jeopardising general wellbeing and health-related quality of life as judged by the investigator.
* Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy during the study period.
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
* Currently participating, or participated within the last 30 days, in another interventional clinical investigation involving an investigational drug or device.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/08/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/09/2020
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Sample size
Target
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Accrual to date
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Final
29
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sydney Cochlear Implant Centre - Gladesville
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Recruitment hospital [2]
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The Royal Victorian Eye and Ear Hospital - Melbourne
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Recruitment postcode(s) [1]
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- Gladesville
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Recruitment postcode(s) [2]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Hong Kong
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State/province [1]
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Hong Kong
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Cochlear
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Statistiska Konsultgruppen
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided sensorineural deafness.
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Trial website
https://clinicaltrials.gov/study/NCT04041700
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Trial related presentations / publications
Briggs R, Birman CS, Baulderstone N, Lewis AT, Ng IHY, Ostblom A, Rousset A, Tari S, Tong MCF, Cowan R. Clinical Performance, Safety, and Patient-Reported Outcomes of an Active Osseointegrated Steady-State Implant System. Otol Neurotol. 2022 Aug 1;43(7):827-834. doi: 10.1097/MAO.0000000000003590.
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Public notes
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Contacts
Principal investigator
Name
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Karin Ganlöv
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Address
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Cochlear
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/00/NCT04041700/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/00/NCT04041700/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04041700