Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removable Oral Appliance (SoundBite)

Study Overview
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Brief Summary
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The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.

Official Title
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Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removable Oral Appliance (SoundBite)

Conditions
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Single Sided Deafness

Intervention / Treatment
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* Device: SoundBite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be current users of a surgically implanted digitally programmable surgically implanted bone conduction device Must be >18, <80 years old Must be fluent in English, as determined by the PI Must have diagnosis of SSD, time since onset (≥3 months) Must have at least two contiguous molar or premolar teeth with no untreated tooth decay. Patients with tooth decay present are to first have restorations before being fitted for SoundBite Healthy attachment to those teeth with tooth pockets limited to no more than 5mm Exclusion Criteria: Subjects with known hypersensitivity to any of the components including allergies to polymers. Subjects that are unable to use their hands such as quadriplegics or others that are unable to comply with the warnings in the product's labeling. Subjects with known or active secondary medical conditions associated with variable sensorineural hearing loss

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SoundBite<br>SoundBite will be used for the first 30 days | Device: SoundBite<br>* Non-surgical removable bone conduction device via the teeth.<br>* Other names: The SoundBite Hearing System;|
| Other: Surgically Implanted BCD<br>The subject's own surgically implanted bone conduction device will be used for the first 30 days. | Device: SoundBite<br>* Non-surgical removable bone conduction device via the teeth.<br>* Other names: The SoundBite Hearing System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APHAB Questionnaire | Comparison of the SoundBite™ System and surgically implanted bone conduction devices | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single Sided Deafness Questionnaire | Comparison of the SoundBite™ System and surgically implanted BCD systems. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single Sided Deafness, SSD, Unilateral hearing loss