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Completed

NCT Number: NCT04041700

Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System

The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided sensorineural deafness.

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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

Sydney Cochlear Implant Centre, Gladesville, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject with conductive hearing loss or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of ≤ 55 dB sensorineural hearing loss.

OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 (mean of 0.5, 1, 2 and 3 kHz) of ≤ 20 dB sensorineural hearing loss in the good ear OR subject who is indicated for an (Air Conduction-Contralateral Routing of Signal (AC CROS) but-for some reason-cannot or will not use an AC CROS.

  • Adult subjects (18 years or older).
  • Previous experience from amplified sound through properly fitted amplification (for example but not limited to Hearing aid, Contralateral Routing of Signal (CROS) device, Bone conduction hearing device on softband).
  • Candidate is a fluent speaker in the language used to assess speech perception performance.
  • Willing and able to provide written informed consent

Exclusion criteria

  • Uncontrolled diabetes as judged by the investigator.
  • Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.
  • Insufficient bone quality and quantity to support successful implant placement.
  • Previous surgery and/or implantation with any bone conduction/active device on the side to be implanted, which may jeopardise the implantation and use of the Osia 2 system, as judged by the investigator.
  • Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.
  • 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.
  • Condition with a likely negative progression and/or with expected relapses jeopardising general wellbeing and health-related quality of life as judged by the investigator.
  • Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy during the study period.
  • Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
  • Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
  • Currently participating, or participated within the last 30 days, in another interventional clinical investigation involving an investigational drug or device.

Treatment and study plan

Osia 2 System

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 processor.

Primary outcomes

  1. Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds

    Time frame: Baseline before surgery, 3 months after surgery

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

  2. Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise

    Time frame: Baseline before surgery, 3 months after surgery

    Speech-to-noise ratio, 50% speech understanding

Secondary outcomes

  1. Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds

    Time frame: Baseline before surgery, 4 weeks and 6 months after surgery

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

  2. Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise

    Time frame: Baseline before surgery, 4 weeks and 6 months after surgery

    Speech-to-noise ratio, 50% speech understanding

  3. Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds

    Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery

    Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz]

  4. Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet

    Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery

    % correctly perceived words at 50dB, 65dB and 80dB SPL

  5. Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire

    Time frame: Baseline before surgery, 3 months and 6 months after surgery

    Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Osia 2 System from the pre-operative unaided situation. The absolute APHAB scale is between 0 and 100%, where 0% indicates no problems and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an impairment, a negative value an improvement.

  6. Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire

    Time frame: Baseline before surgery, 3 months and 6 months after surgery

    Measuring change of speech, spatial and hearing experiences with the Osia 2 System from the pe-operative unaided situation. A scale from 0 to 10 is used, where 0 represents "can not hear at all", and 10 "hear perfectly". The change from unaided to aided hearing is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.

  7. Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire

    Time frame: Baseline before surgery, 3 months and 6 months after surgery

    Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Osia 2 System compared to the pre-operative unaided situation. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from unaided to aided hearing is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.

  8. Surgical Information: Soft Tissue Thickness

    Time frame: Baseline before surgery or at surgery

    Measured in mm

  9. Surgical Information: Surgery Time

    Time frame: At surgery

    Time in minutes between first incision to last suture

  10. Surgical Information: Bone Polishing/Removal at the Actuator Site

    Time frame: At surgery

    Yes/No

  11. Surgical Information: BI300 Implant Length

    Time frame: At surgery

    3 mm/4 mm

  12. Surgical Information: Location of BI300 Implant

    Time frame: At surgery

    Measured in mm between the ear canal and the center of the actuator

  13. Surgical Information: Type of Anesthesia

    Time frame: At surgery

    General/local

  14. Surgical Information: Soft Tissue Reduction

    Time frame: At surgery

    Yes/No

  15. Surgical Information: Surgical Incision Type

    Time frame: At surgery

    Examples: C-shaped/S-shaped/straight

  16. Surgical Information: Location of the Surgical Incision in Relation to the Actuator

    Time frame: At surgery

    Anterior/posterior

  17. Surgical Information: Estimated Length of the Surgical Incision

    Time frame: At surgery

    Measured in mm

  18. Surgical Information: Placement of the Coil

    Time frame: At surgery

    Periosteal pocket (under periosteal)/on top of periosteum/on top of muscle)

  19. Usability Information: Magnet Choice

    Time frame: At 4 weeks, 6 weeks, 3 months and 6 months after surgery

    Magnet strength ranging from 1 to 4 where 1 is the weakest and 4 the strongest. A magnet allows the external sound processor to be placed in the correct position over the implanted system including an internal magnet.

  20. Usability Information: Sound Processor Retention

    Time frame: At 4 weeks, 6 weeks, 3 months and 6 months after surgery

    Assessed via a Visual Analog Scale 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention

  21. Usability Information: Sound Processor Wearing Comfort

    Time frame: At 4 weeks, 6 weeks, 3 months and 6 months after surgery

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

  22. Usability Information: Use of SoftWear Pad

    Time frame: At 6 weeks, 3 months and 6 months after surgery

    Yes/No

  23. Usability Information: Daily Use of Sound Processor

    Time frame: At 6 weeks, 3 months and 6 months after surgery

    Average hours of daily use

  24. Usability Information: Daily Streaming Time of Sound Processor

    Time frame: At 6 weeks, 3 months and 6 months after surgery

    Average hours of daily streaming

  25. Usability Information: Battery Lifetime of Sound Processor

    Time frame: At 6 weeks, 3 months and 6 months after surgery

    Average hours of battery lifetime

  26. Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds

    Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery

    Free-field [Pure Tone Average (PTA) 4, Mean of 0.5, 1, 2 and 4 kHz].

  27. Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds

    Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery

    Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz].

  28. Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Adaptive Speech Recognition in Noise

    Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery

    Signal-to-noise ratio, 50% speech understanding

  29. Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet

    Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery

    % correctly perceived words at 50dB, 65dB and 80dB SPL

  30. Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct

    Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery

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

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Collaborators

  • Statistiska Konsultgruppen

Registry information

Official study title

A Prospective, Multicentre, Open Clinical Investigation Evaluating Clinical Performance, Safety and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System (OSI) in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 1, 2019
Registry last updated
Aug 18, 2021

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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