Ambispective Clinical Evaluation of Sophono™

Study Overview
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Brief Summary
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Study to accumulate post-market clinical evidence for the safety and effectiveness of the Sophono Alpha 2 and Alpha 2 MPO systems in subjects diagnosed with conductive hearing loss, single-sided deafness and mixed hearing loss who currently have or have had the Sophono implant.

Official Title
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Ambispective Clinical Evaluation of Sophono™

Conditions
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Conductive Hearing Loss, Single-Sided Deafness, Mixed Hearing Loss

Intervention / Treatment
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* Device: Sophono Bone Conduction Hearing Systems


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any subject who currently has or who has had the Sophono implant (including those who have been explanted) Has or has had Sophono implant for 3 months or longer Exclusion Criteria: Subject has implant but is unable or unwilling to perform audiologic testing Subject is currently participating in another clinical study and has not been approved for concurrent enrollment by the Study Sponsor

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects<br>Diagnosed with CHL, SSD and mixed HL who currently have or have had the Sophono implant | Device: Sophono Bone Conduction Hearing Systems<br>* The Sophono Bone Conduction Hearing Systems are a family of sound processors and accessories that operate on the principle of BC of sound vibrations. The Sophono Bone Conduction Hearing Systems transmits audio vibrations through the skin into the bone where sound is sensed by the inner ear/cochlea. The Sophono Sound Processor is magnetically attracted to the Magnetic Implant and Magnetic Spacer. The Magnetic Implant, which is secured to the skull bone, affixes the Magnetic Spacer to the head transcutaneously through magnetic attraction forces, and the Sound Processor is magnetically affixed to the Magnetic Spacer. Vibration from the Sound Processor is transduced through the Magnetic Spacer to the Magnetic Implant and through the bone to the inner ear.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety of the Sophono implant | The primary safety endpoint is the proportion of AEs related to the Sophono implant, which will be assessed through retrospective surgical chart review and prospective ENT exam. | From Implantation to Study Visit, up to 6 years | 
| Assess the effectiveness of the Sophono Alpha 2 MPO processor | The primary efficacy endpoint is the difference (gain) in the free-field pure tone audiometry assessed by pure tone average (PTA) unaided (AC) and aided (BC) by the Alpha 2 MPO processor. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effectiveness of the Sophono Alpha 2 processor to the Alpha 2 MPO processor | The difference in the free-field pure tone audiometry assessed by PTA aided by Alpha 2 processor compared to the PTA aided by Alpha 2 MPO processor | 1 day | 
| Assess the effectiveness of the Sophono Alpha 2 and the Sophono Alpha 2 MPO over time | Change over time of PTA in the Sophono Alpha 2 and Alpha 2 MPO | From Processor fitting to Study Visit, up to 4 years | 
| Assess subject satisfaction after system use | Subject satisfaction, via non-validated satisfaction questions | 1 day | 
| Assess QOL after system use | QOL assessment through validated Abbreviated Profile of Hearing Aid Benefit (APHAB)™ assessment | 1 day |