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Long Term Clinical Investigation to Evaluate Clinical 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
Active Osseointegrated Steady-State Implant System (OSI)
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject has performed Hearing assessment at 3 and/or 6 months in the clinical investigation CBAS5751
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • 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
  • Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator

Sites / Locations

  • SCIC / NextSense
  • HEARnet Clinical studies
  • 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

Active Osseointegrated Steady-State Implant System (OSI)

Arm Description

Outcomes

Primary Outcome Measures

Number and type of reported Adverse events
The adverse events are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by system organ class system
Number and type of reported Device deficiencies
The device deficiencies are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by relationship
Concomitant medication used
Concomitant medication are collected from the participant's last visit in study CBAS5751 (6 months post-surgery)
Socio-economic health care data via the Client Service Receipt Inventory (CSRI) survey
Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected
Socio-economic health care data via the Client Service Receipt Inventory (CSRI) survey
Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected
Change in audiometric thresholds with the Active Osseointegrated Steady-State Implant System at 12 months post-surgery and 24 months post-surgery compared to preoperative thresholds via an audiogram
Bone- and air conduction thresholds, masked and unmasked

Secondary Outcome Measures

Change in hearing performance with the Active Osseointegrated Steady-State Implant System at 12 months and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study assessed via audiometric thresholds
Sound-field (Pure Tone Average 4, mean of 0.5, 1, 2 and 4 kHz)
Change in hearing performance with the Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study assessed via audiometric thresholds
Sound-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 Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study assessed via adaptive speech recognition in noise
Speech-to-noise ratio, 50% speech understanding
Change in hearing performance with the Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study 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)
Difference in self-reported hearing outcome with the Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Assessed via Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. APHAB produces a global score and scores for four subscales: Ease of Communication, Reverberation, Background Noise, and Aversiveness. Global score is the average of all subscales. All scales range from 0-100%, where 0% indicates no problem and 100% indicates always problem. A decrease in the APHAB values indicates an improvement. The difference in scores will be presented. A positive value indicates an improvement, a negative value an impairment.
Change in self-reported hearing outcome with the Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Assessed via the Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire. Measuring change of speech, spatial and hearing experiences with the Active Osseointegrated Steady-State Implant System. The Total score summarizes the parameters speech, spatial and hearing. A scale from 0 to 10 is used, where 0 represents "can not hear at all", and 10 "hear perfectly". An increase of an SSQ value reflects an improvement. The change in scores will be presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
Change in health-related quality of life with the Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Assessed via the Health Utilities Index (HUI) questionnaire. Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index when wearing the Active Osseointegrated Steady-State Implant System. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change in scores will be presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Participant satisfaction with the investigational device (every-day situation and self-esteem) assessed on a Likert Scale
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 7, where 1 represent Much worse and 7 represent Much better.
Participant satisfaction with the investigational device (easiness to use) assessed on a Likert Scale
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5 where 1 represent Very difficult and 5 represent Very easy.
Participant satisfaction with the investigational device (durability of the device and sound quality) assessed on a Likert Scale
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5, where 1 represent Very dissatisfied and 5 represent Very satisfied.
Participant satisfaction with the investigational device (overall satisfaction) with question Yes/No.
Participant satisfaction with the investigational device (every-day situation and self-esteem) assessed on a Likert Scale
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 7, where 1 represent Much worse and 7 represent Much better.
Participant satisfaction with the investigational device (easiness to use) assessed on a Likert Scale
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5 where 1 represent Very difficult and 5 represent Very easy.
Participant satisfaction with the investigational device (durability of the device and sound quality) assessed on a Likert Scale
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5, where 1 represent Very dissatisfied and 5 represent Very satisfied.
Participant satisfaction with the investigational device (overall satisfaction) with question Yes/No.
Change in daily use of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Average hours of daily use during the last week before each follow up visit
Change in daily streaming time of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Average hours of daily streaming during the last week before each follow up visit
Change in battery lifetime of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Average hours of battery lifetime for a single battery during the last week before each follow up visit
Change in magnet choice of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Magnet strength ranging from 1 to 4, strength 1 being the weakest and 4 the strongest. If the magnet strength has been changed the reason for change is captured in free text
Change in use of SoftWear pad for the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
SoftWear pad usage: Yes or No
Change in retention of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Assessed via a Visual Analog Scale (VAS) 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention.
Change in wearing comfort of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Assessed via a Visual Analog Scale (VAS) 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort.

Full Information

First Posted
February 10, 2021
Last Updated
March 24, 2022
Sponsor
Cochlear
Collaborators
Statistiska Konsultgruppen
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1. Study Identification

Unique Protocol Identification Number
NCT04754477
Brief Title
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
Official Title
A Multicentre, Open, Long-term Clinical Investigation Evaluating Safety, Performance and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
March 21, 2022 (Actual)
Study Completion Date
March 21, 2022 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751. In addition, questions regarding device satisfaction, sound satisfaction, usability and health care utilisation will be asked.

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
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Osseointegrated Steady-State Implant System (OSI)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Active Osseointegrated Steady-State Implant System (OSI)
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 process
Primary Outcome Measure Information:
Title
Number and type of reported Adverse events
Description
The adverse events are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by system organ class system
Time Frame
6 months post-surgery to 24 months post-surgery
Title
Number and type of reported Device deficiencies
Description
The device deficiencies are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by relationship
Time Frame
6 months post-surgery to 24 months post-surgery
Title
Concomitant medication used
Description
Concomitant medication are collected from the participant's last visit in study CBAS5751 (6 months post-surgery)
Time Frame
6 months post-surgery to 24 months post-surgery
Title
Socio-economic health care data via the Client Service Receipt Inventory (CSRI) survey
Description
Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected
Time Frame
12 months post-surgery
Title
Socio-economic health care data via the Client Service Receipt Inventory (CSRI) survey
Description
Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected
Time Frame
24 months post-surgery
Title
Change in audiometric thresholds with the Active Osseointegrated Steady-State Implant System at 12 months post-surgery and 24 months post-surgery compared to preoperative thresholds via an audiogram
Description
Bone- and air conduction thresholds, masked and unmasked
Time Frame
Baseline before surgery, 12 months and 24 months post-surgery
Secondary Outcome Measure Information:
Title
Change in hearing performance with the Active Osseointegrated Steady-State Implant System at 12 months and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study assessed via audiometric thresholds
Description
Sound-field (Pure Tone Average 4, mean of 0.5, 1, 2 and 4 kHz)
Time Frame
3 or 6 months post-surgery, 12 and 24 months post-surgery
Title
Change in hearing performance with the Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study assessed via audiometric thresholds
Description
Sound-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
3 or 6 months post-surgery, 12 and 24 months post-surgery
Title
Change in hearing performance with the Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study assessed via adaptive speech recognition in noise
Description
Speech-to-noise ratio, 50% speech understanding
Time Frame
3 or 6 months post-surgery, 12 and 24 months post-surgery
Title
Change in hearing performance with the Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study 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
3 or 6 months post-surgery, 12 and 24 months post-surgery
Title
Difference in self-reported hearing outcome with the Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Description
Assessed via Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. APHAB produces a global score and scores for four subscales: Ease of Communication, Reverberation, Background Noise, and Aversiveness. Global score is the average of all subscales. All scales range from 0-100%, where 0% indicates no problem and 100% indicates always problem. A decrease in the APHAB values indicates an improvement. The difference in scores will be presented. A positive value indicates an improvement, a negative value an impairment.
Time Frame
3 or 6 months post-surgery, 12 and 24 months post-surgery
Title
Change in self-reported hearing outcome with the Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Description
Assessed via the Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire. Measuring change of speech, spatial and hearing experiences with the Active Osseointegrated Steady-State Implant System. The Total score summarizes the parameters speech, spatial and hearing. A scale from 0 to 10 is used, where 0 represents "can not hear at all", and 10 "hear perfectly". An increase of an SSQ value reflects an improvement. The change in scores will be presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
Time Frame
3 or 6 months post-surgery, 12 and 24 months post-surgery
Title
Change in health-related quality of life with the Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Description
Assessed via the Health Utilities Index (HUI) questionnaire. Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index when wearing the Active Osseointegrated Steady-State Implant System. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change in scores will be presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Time Frame
3 or 6 months post-surgery, 12 and 24 months post-surgery
Title
Participant satisfaction with the investigational device (every-day situation and self-esteem) assessed on a Likert Scale
Description
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 7, where 1 represent Much worse and 7 represent Much better.
Time Frame
12 months post-surgery
Title
Participant satisfaction with the investigational device (easiness to use) assessed on a Likert Scale
Description
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5 where 1 represent Very difficult and 5 represent Very easy.
Time Frame
12 months post-surgery
Title
Participant satisfaction with the investigational device (durability of the device and sound quality) assessed on a Likert Scale
Description
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5, where 1 represent Very dissatisfied and 5 represent Very satisfied.
Time Frame
12 months post-surgery
Title
Participant satisfaction with the investigational device (overall satisfaction) with question Yes/No.
Time Frame
12 months post-surgery
Title
Participant satisfaction with the investigational device (every-day situation and self-esteem) assessed on a Likert Scale
Description
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 7, where 1 represent Much worse and 7 represent Much better.
Time Frame
24 months post-surgery
Title
Participant satisfaction with the investigational device (easiness to use) assessed on a Likert Scale
Description
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5 where 1 represent Very difficult and 5 represent Very easy.
Time Frame
24 months post-surgery
Title
Participant satisfaction with the investigational device (durability of the device and sound quality) assessed on a Likert Scale
Description
To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5, where 1 represent Very dissatisfied and 5 represent Very satisfied.
Time Frame
24 months post-surgery
Title
Participant satisfaction with the investigational device (overall satisfaction) with question Yes/No.
Time Frame
24 months post-surgery
Title
Change in daily use of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Description
Average hours of daily use during the last week before each follow up visit
Time Frame
3 or 6 months post-surgery, 12 and 24 months post-surgery
Title
Change in daily streaming time of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Description
Average hours of daily streaming during the last week before each follow up visit
Time Frame
3 or 6 months post-surgery, 12 and 24 months post-surgery
Title
Change in battery lifetime of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Description
Average hours of battery lifetime for a single battery during the last week before each follow up visit
Time Frame
3 or 6 months post-surgery, 12 and 24 months post-surgery
Title
Change in magnet choice of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Description
Magnet strength ranging from 1 to 4, strength 1 being the weakest and 4 the strongest. If the magnet strength has been changed the reason for change is captured in free text
Time Frame
3 or 6 months post-surgery, 12 and 24 months post-surgery
Title
Change in use of SoftWear pad for the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Description
SoftWear pad usage: Yes or No
Time Frame
3 or 6 months post-surgery, 12 and 24 months post-surgery
Title
Change in retention of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Description
Assessed via a Visual Analog Scale (VAS) 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention.
Time Frame
3 or 6 months post-surgery, 12 and 24 months post-surgery
Title
Change in wearing comfort of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study
Description
Assessed via a Visual Analog Scale (VAS) 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort.
Time Frame
3 or 6 months post-surgery, 12 and 24 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has performed Hearing assessment at 3 and/or 6 months in the clinical investigation CBAS5751 Willing and able to provide written informed consent Exclusion Criteria: 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 Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Ganlöv, MD
Organizational Affiliation
Cochlear
Official's Role
Study Director
Facility Information:
Facility Name
SCIC / NextSense
City
Gladesville
State/Province
New South Wales
ZIP/Postal Code
2111
Country
Australia
Facility Name
HEARnet Clinical studies
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
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
IPD Sharing Plan Description
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.

Learn more about this trial

Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System

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