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

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.

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Active Osseointegrated Steady-State Implant System (OSI)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Gladesville, New South Wales, Australia, 2111
      • SCIC / NextSense
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • HEARnet Clinical Studies
• Hong Kong
  • Hong Kong, Hong Kong
    • Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine. The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Osseointegrated Steady-State Implant System (OSI)	Device: Active Osseointegrated Steady-State Implant System (OSI); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months post-surgery to 24 months post-surgery
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	6 months post-surgery to 24 months post-surgery
Concomitant medication used	Concomitant medication are collected from the participant's last visit in study CBAS5751 (6 months post-surgery)	6 months post-surgery to 24 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	12 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	24 months post-surgery
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	Baseline before surgery, 12 months and 24 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 or 6 months post-surgery, 12 and 24 months post-surgery
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]	3 or 6 months post-surgery, 12 and 24 months post-surgery
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	3 or 6 months post-surgery, 12 and 24 months post-surgery
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)	3 or 6 months post-surgery, 12 and 24 months post-surgery
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.	3 or 6 months post-surgery, 12 and 24 months post-surgery
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.	3 or 6 months post-surgery, 12 and 24 months post-surgery
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.	3 or 6 months post-surgery, 12 and 24 months post-surgery
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.	12 months post-surgery
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.	12 months post-surgery
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.	12 months post-surgery
Participant satisfaction with the investigational device (overall satisfaction) with question Yes/No.		12 months post-surgery
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.	24 months post-surgery
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.	24 months post-surgery
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.	24 months post-surgery
Participant satisfaction with the investigational device (overall satisfaction) with question Yes/No.		24 months post-surgery
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	3 or 6 months post-surgery, 12 and 24 months post-surgery
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	3 or 6 months post-surgery, 12 and 24 months post-surgery
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	3 or 6 months post-surgery, 12 and 24 months post-surgery
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	3 or 6 months post-surgery, 12 and 24 months post-surgery
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	3 or 6 months post-surgery, 12 and 24 months post-surgery
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.	3 or 6 months post-surgery, 12 and 24 months post-surgery
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.	3 or 6 months post-surgery, 12 and 24 months post-surgery

Collaborators and Investigators

• Sponsor: Cochlear
• Collaborators: Statistiska Konsultgruppen
• Investigators: Study Director: Karin Ganlöv, MD, Cochlear

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Actual): March 21, 2022
• Study Completion (Actual): March 21, 2022

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Hearing Loss, Conductive; Hearing Loss, Mixed; Deafness, sensorineural single-sided
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: CBAS5793

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• 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