Osia CPT Code Study

Study Overview
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Brief Summary
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To evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed conductive hearing loss in a US cohort.

Official Title
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A Post-market Interventional Cohort Study Evaluating the Clinical Efficacy of the Osia 2 System in the US Market.

Conditions
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Conductive Hearing Loss, Mixed 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: Willing and able to provide written informed consent. Proficient in English. Hearing loss etiology of Conductive or Mixed Conductive loss. Bone conduction PTA (.5, 1, 2, and 3 kHz) better than or equal to 55 dB HL in the treatment ear. Aged 18 years and older. Exclusion Criteria: Unwilling to wear the treatment device or comply with the surgical and rehabilitation requirements of the study. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. Medical, audiological or psychological conditions, as judged by the investigator that might contraindicate participation in the clinical investigation. 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 contractors engaged by Cochlear for the purposes of this investigation. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device. Prior experience with a surgical bone conduction treatment option Insufficient bone quality to support the BI300 implant as determined by the surgeon

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>Osia 2 Active Osseointegrated Implant System for Bone Conduction | Device: Osia 2 System<br>* The external Sound Processor, Osia 2 Active Osseointegrated Implant System for Bone Conduction, captures and digitizes the sound which is transferred to the internal implant where it is converted to an electrical signal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery | Assessed with the Quick SIN test preoperative and at 3 months post-surgery. The Quick SIN test has a score range from +25.5 dB (decibel) SNR (signal-to-noise ratio) to -5 dB SNR. The participants are tested on 4 tests lists; each consists of 6 sentences (with 5 key words per sentence) that are presented at signal-to-noise ratios (SNR) which are decreased manually in 5-dB steps from 25 to 0. The key words in sentences are scored and counted as correct from an easy to difficult or unfavorable SNR. The best possible score on this test would be that of -5 dB SNR where all of the key words are repeated back correctly as a function of the SNR. The mean unaided preoperative score is substracted from the aided score at 3 months. A lower score indicates a better performance. | Preoperative, 3 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Device or Procedure Related Adverse Events | A device or procedure related adverse event (AE) is an AE for which a causal relationship between the use of the medical device and the AE cannot be ruled out. All related AEs are reported. | 6 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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conductive hearing loss, mixed hearing loss