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

Hearing Loss Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04754477
• Other study ID #: CBAS5793
• Status: Completed
• Phase: N/A
• Start date: May 6, 2021
• Est. completion date: March 21, 2022

Study information

• Verified date: January 2024
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 21, 2022
• Est. primary completion date: March 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

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

Locations

Country	Name	City	State
Australia	HEARnet Clinical studies	Carlton	Victoria
Australia	SCIC / NextSense	Gladesville	New South Wales
Hong Kong	Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine. The Chinese University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Cochlear	Statistiska Konsultgruppen

Countries where clinical trial is conducted

Australia,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.		12 months post-surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.		24 months post-surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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