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Completed

NCT Number: NCT04754477

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

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.

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Key information

Conditions

Hearing Loss Deafness Ear Diseases Hearing Disorders Hearing Loss, Conductive Hearing Loss, Mixed Conductive-Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SCIC / NextSense, Gladesville, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Osseointegrated Steady-State Implant System (OSI)

Device

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 outcomes

  1. Number and Type of Reported Adverse Events

    Time frame: 6 months post-surgery to 24 months post-surgery

    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

  2. Number and Type of Reported Device Deficiencies

    Time frame: 6 months post-surgery to 24 months post-surgery

    The device deficiencies are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by relationship

  3. Concomitant Medication Used

    Time frame: 6 months post-surgery to 24 months post-surgery

    Concomitant medication are collected from the participant's last visit in study CBAS5751 (6 months post-surgery)

  4. Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey

    Time frame: 12 months post-surgery

    Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected

  5. Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey

    Time frame: 24 months post-surgery

    Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected

  6. 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

    Time frame: Baseline before surgery, 12 months and 24 months post-surgery

    Bone- and air conduction thresholds, masked and unmasked

Secondary outcomes

  1. 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

    Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery

    Sound-field (Pure Tone Average 4, mean of 0.5, 1, 2 and 4 kHz)

  2. 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

    Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery

    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. 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

    Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery

    Speech-to-noise ratio, 50% speech understanding

  4. 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

    Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery

    BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz)

  5. 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

    Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery

    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.

  6. 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

    Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery

    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.

  7. 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

    Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery

    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.

  8. Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale

    Time frame: 12 months post-surgery

    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.

  9. Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale

    Time frame: 12 months post-surgery

    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.

  10. Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale

    Time frame: 12 months post-surgery

    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.

  11. Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.

    Time frame: 12 months post-surgery

  12. Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale

    Time frame: 24 months post-surgery

    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.

  13. Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale

    Time frame: 24 months post-surgery

    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.

  14. Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale

    Time frame: 24 months post-surgery

    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.

  15. Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.

    Time frame: 24 months post-surgery

  16. 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

    Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery

    Average hours of daily use during the last week before each follow up visit

  17. 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

    Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery

    Average hours of daily streaming during the last week before each follow up visit

  18. 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

    Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery

    Average hours of battery lifetime for a single battery during the last week before each follow up visit

  19. 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

    Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery

    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

  20. 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

    Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery

    SoftWear pad usage: Yes or No

  21. 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

    Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery

    Assessed via a Visual Analog Scale (VAS) 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention.

  22. 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

    Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery

    Assessed via a Visual Analog Scale (VAS) 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Collaborators

  • Statistiska Konsultgruppen

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2021
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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