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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Osia 2 system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osia 2 system<br> | Device: Osia 2 system<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds | Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz) | Baseline before surgery, 3 months after surgery | 
| 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 | Speech-to-noise ratio, 50% speech understanding | Baseline before surgery, 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz) | Baseline before surgery, 4 weeks and 6 months after surgery | 
| 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 | Speech-to-noise ratio, 50% speech understanding | Baseline before surgery, 4 weeks and 6 months after surgery | 
| 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 | Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz] | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery | 
| 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 | % correctly perceived words at 50dB, 65dB and 80dB SPL | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery | 
| 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 | 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. | Baseline before surgery, 3 months and 6 months after surgery | 
| 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 | 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. | Baseline before surgery, 3 months and 6 months after surgery | 
| 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 | 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. | Baseline before surgery, 3 months and 6 months after surgery | 
| Surgical Information: Soft Tissue Thickness | Measured in mm | Baseline before surgery or at surgery | 
| Surgical Information: Surgery Time | Time in minutes between first incision to last suture | At surgery | 
| Surgical Information: Bone Polishing/Removal at the Actuator Site | Yes/No | At surgery | 
| Surgical Information: BI300 Implant Length | 3 mm/4 mm | At surgery | 
| Surgical Information: Location of BI300 Implant | Measured in mm between the ear canal and the center of the actuator | At surgery | 
| Surgical Information: Type of Anesthesia | General/local | At surgery | 
| Surgical Information: Soft Tissue Reduction | Yes/No | At surgery | 
| Surgical Information: Surgical Incision Type | Examples: C-shaped/S-shaped/straight | At surgery | 
| Surgical Information: Location of the Surgical Incision in Relation to the Actuator | Anterior/posterior | At surgery | 
| Surgical Information: Estimated Length of the Surgical Incision | Measured in mm | At surgery | 
| Surgical Information: Placement of the Coil | Periosteal pocket (under periosteal)/on top of periosteum/on top of muscle) | At surgery | 
| Usability Information: Magnet Choice | 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. | At 4 weeks, 6 weeks, 3 months and 6 months after surgery | 
| Usability Information: Sound Processor Retention | Assessed via a Visual Analog Scale 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention | At 4 weeks, 6 weeks, 3 months and 6 months after surgery | 
| Usability Information: Sound Processor Wearing Comfort | Assessed via a Visual Analog Scale 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort | At 4 weeks, 6 weeks, 3 months and 6 months after surgery | 
| Usability Information: Use of SoftWear Pad | Yes/No | At 6 weeks, 3 months and 6 months after surgery | 
| Usability Information: Daily Use of Sound Processor | Average hours of daily use | At 6 weeks, 3 months and 6 months after surgery | 
| Usability Information: Daily Streaming Time of Sound Processor | Average hours of daily streaming | At 6 weeks, 3 months and 6 months after surgery | 
| Usability Information: Battery Lifetime of Sound Processor | Average hours of battery lifetime | At 6 weeks, 3 months and 6 months after surgery | 
| 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 | Free-field [Pure Tone Average (PTA) 4, Mean of 0.5, 1, 2 and 4 kHz]. | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery | 
| 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 | Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz]. | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery | 
| 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 | Signal-to-noise ratio, 50% speech understanding | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery | 
| 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 | % correctly perceived words at 50dB, 65dB and 80dB SPL | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery | 
| 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 | BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz) | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hearing Loss, Conductive, Hearing Loss, Mixed, Deafness, sensorineural single-sided