Clinical trial NCT04754477: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Hearing Loss, Conductive
Hearing Loss, Mixed
Deafness, sensorineural single-sided
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: Statistiska Konsultgruppen
First posted: 2021-02-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number and Type of Reported Adverse Events
timeFrame: 6 months post-surgery to 24 months post-surgery
measure: Number and Type of Reported Device Deficiencies
timeFrame: 6 months post-surgery to 24 months post-surgery
measure: Concomitant Medication Used
timeFrame: 6 months post-surgery to 24 months post-surgery
measure: Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
timeFrame: 12 months post-surgery
measure: Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
timeFrame: 24 months post-surgery
measure: 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
timeFrame: Baseline before surgery, 12 months and 24 months post-surgery
Secondary outcomes:
measure: 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
timeFrame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
measure: 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
timeFrame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
measure: 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
timeFrame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
measure: 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
timeFrame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
measure: 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
timeFrame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
measure: 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
timeFrame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
measure: 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
timeFrame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
measure: Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
timeFrame: 12 months post-surgery
measure: Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale
timeFrame: 12 months post-surgery
measure: Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
timeFrame: 12 months post-surgery
measure: Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.
timeFrame: 12 months post-surgery
measure: Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
timeFrame: 24 months post-surgery
measure: Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale
timeFrame: 24 months post-surgery
measure: Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
timeFrame: 24 months post-surgery
measure: Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.
timeFrame: 24 months post-surgery
measure: 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
timeFrame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
measure: 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
timeFrame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
measure: 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
timeFrame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
measure: 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
timeFrame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
measure: 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
timeFrame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
measure: 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
timeFrame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
measure: 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
timeFrame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Other outcomes:
Locations:
city: Gladesville
country: Australia
facility: SCIC / NextSense
state: New South Wales
city: Carlton
country: Australia
facility: HEARnet Clinical studies
state: Victoria
city: Hong Kong
country: Hong Kong
facility: Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine. The Chinese University of Hong Kong
Study officials:
affiliation: Cochlear
name: Karin Ganlöv, MD
role: STUDY_DIRECTOR
References: