Back to resultsClinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Osia 2 system
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Hearing Loss, Conductive, Hearing Loss, Mixed, Deafness, sensorineural single-sided
Eligibility Criteria
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
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.
Sites / Locations
- Sydney Cochlear Implant Centre
- The Royal Victorian Eye and Ear Hospital
- Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine. The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Osia 2 system
Arm Description
Outcomes
Primary Outcome Measures
Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds
Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)
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
Speech-to-noise ratio, 50% speech understanding
Secondary Outcome Measures
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
Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)
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
Speech-to-noise ratio, 50% speech understanding
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
Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz]
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
% correctly perceived words at 50dB, 65dB and 80dB SPL
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
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.
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
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.
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
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.
Surgical Information: Soft Tissue Thickness
Measured in mm
Surgical Information: Surgery Time
Time in minutes between first incision to last suture
Surgical Information: Bone Polishing/Removal at the Actuator Site
Yes/No
Surgical Information: BI300 Implant Length
3 mm/4 mm
Surgical Information: Location of BI300 Implant
Measured in mm between the ear canal and the center of the actuator
Surgical Information: Type of Anesthesia
General/local
Surgical Information: Soft Tissue Reduction
Yes/No
Surgical Information: Surgical Incision Type
Examples: C-shaped/S-shaped/straight
Surgical Information: Location of the Surgical Incision in Relation to the Actuator
Anterior/posterior
Surgical Information: Estimated Length of the Surgical Incision
Measured in mm
Surgical Information: Placement of the Coil
Periosteal pocket (under periosteal)/on top of periosteum/on top of muscle)
Usability Information: Magnet Choice
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.
Usability Information: Sound Processor Retention
Assessed via a Visual Analog Scale 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention
Usability Information: Sound Processor Wearing Comfort
Assessed via a Visual Analog Scale 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort
Usability Information: Use of SoftWear Pad
Yes/No
Usability Information: Daily Use of Sound Processor
Average hours of daily use
Usability Information: Daily Streaming Time of Sound Processor
Average hours of daily streaming
Usability Information: Battery Lifetime of Sound Processor
Average hours of battery lifetime
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
Free-field [Pure Tone Average (PTA) 4, Mean of 0.5, 1, 2 and 4 kHz].
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
Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz].
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
Signal-to-noise ratio, 50% speech understanding
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
% correctly perceived words at 50dB, 65dB and 80dB SPL
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
BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz)
Full Information
NCT ID
NCT04041700
First Posted
July 30, 2019
Last Updated
August 17, 2021
Sponsor
Cochlear
Collaborators
Statistiska Konsultgruppen
1. Study Identification
Unique Protocol Identification Number
NCT04041700
Brief Title
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 16, 2019 (Actual)
Primary Completion Date
June 19, 2020 (Actual)
Study Completion Date
September 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
Collaborators
Statistiska Konsultgruppen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Hearing Loss, Conductive, Hearing Loss, Mixed, Deafness, sensorineural single-sided
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Osia 2 system
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Osia 2 system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds
Description
Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)
Time Frame
Baseline before surgery, 3 months after surgery
Title
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
Description
Speech-to-noise ratio, 50% speech understanding
Time Frame
Baseline before surgery, 3 months after surgery
Secondary Outcome Measure Information:
Title
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
Description
Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)
Time Frame
Baseline before surgery, 4 weeks and 6 months after surgery
Title
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
Description
Speech-to-noise ratio, 50% speech understanding
Time Frame
Baseline before surgery, 4 weeks and 6 months after surgery
Title
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
Description
Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz]
Time Frame
Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Title
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
Description
% correctly perceived words at 50dB, 65dB and 80dB SPL
Time Frame
Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Title
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
Description
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.
Time Frame
Baseline before surgery, 3 months and 6 months after surgery
Title
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
Description
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.
Time Frame
Baseline before surgery, 3 months and 6 months after surgery
Title
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
Description
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.
Time Frame
Baseline before surgery, 3 months and 6 months after surgery
Title
Surgical Information: Soft Tissue Thickness
Description
Measured in mm
Time Frame
Baseline before surgery or at surgery
Title
Surgical Information: Surgery Time
Description
Time in minutes between first incision to last suture
Time Frame
At surgery
Title
Surgical Information: Bone Polishing/Removal at the Actuator Site
Description
Yes/No
Time Frame
At surgery
Title
Surgical Information: BI300 Implant Length
Description
3 mm/4 mm
Time Frame
At surgery
Title
Surgical Information: Location of BI300 Implant
Description
Measured in mm between the ear canal and the center of the actuator
Time Frame
At surgery
Title
Surgical Information: Type of Anesthesia
Description
General/local
Time Frame
At surgery
Title
Surgical Information: Soft Tissue Reduction
Description
Yes/No
Time Frame
At surgery
Title
Surgical Information: Surgical Incision Type
Description
Examples: C-shaped/S-shaped/straight
Time Frame
At surgery
Title
Surgical Information: Location of the Surgical Incision in Relation to the Actuator
Description
Anterior/posterior
Time Frame
At surgery
Title
Surgical Information: Estimated Length of the Surgical Incision
Description
Measured in mm
Time Frame
At surgery
Title
Surgical Information: Placement of the Coil
Description
Periosteal pocket (under periosteal)/on top of periosteum/on top of muscle)
Time Frame
At surgery
Title
Usability Information: Magnet Choice
Description
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.
Time Frame
At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Title
Usability Information: Sound Processor Retention
Description
Assessed via a Visual Analog Scale 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention
Time Frame
At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Title
Usability Information: Sound Processor Wearing Comfort
Description
Assessed via a Visual Analog Scale 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort
Time Frame
At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Title
Usability Information: Use of SoftWear Pad
Description
Yes/No
Time Frame
At 6 weeks, 3 months and 6 months after surgery
Title
Usability Information: Daily Use of Sound Processor
Description
Average hours of daily use
Time Frame
At 6 weeks, 3 months and 6 months after surgery
Title
Usability Information: Daily Streaming Time of Sound Processor
Description
Average hours of daily streaming
Time Frame
At 6 weeks, 3 months and 6 months after surgery
Title
Usability Information: Battery Lifetime of Sound Processor
Description
Average hours of battery lifetime
Time Frame
At 6 weeks, 3 months and 6 months after surgery
Title
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
Description
Free-field [Pure Tone Average (PTA) 4, Mean of 0.5, 1, 2 and 4 kHz].
Time Frame
Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Title
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
Description
Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz].
Time Frame
Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Title
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
Description
Signal-to-noise ratio, 50% speech understanding
Time Frame
Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Title
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
Description
% correctly perceived words at 50dB, 65dB and 80dB SPL
Time Frame
Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Title
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
Description
BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz)
Time Frame
Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Ganlöv
Organizational Affiliation
Cochlear
Official's Role
Study Director
Facility Information:
Facility Name
Sydney Cochlear Implant Centre
City
Gladesville
Country
Australia
Facility Name
The Royal Victorian Eye and Ear Hospital
City
Melbourne
Country
Australia
Facility Name
Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine. The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35878640
Citation
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.
Results Reference
derived
Learn more about this trial
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
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