Evaluation of Sound Processor for a Transcutaneous System

Study Overview
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Brief Summary
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A single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and speech intelligibility and self evaluation questionnaires.

Detailed Description
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Bone conduction hearing systems use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. Bone conduction devices currently on the market are divided into three types; transcutaneous direct drive, percutaneous (skin penetrating) direct drive and transcutaneous skin drive bone conduction devices. This evaluation focus on a sound processor used for a transcutaneous system.

Official Title
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Single Center Evaluation of a Sound Processor for a Transcutaneous System

Conditions
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Conductive Hearing Loss, Mixed Hearing Loss

Intervention / Treatment
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* Device: Fusion Sound Processor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects implanted with the Bridging Bone Conductor (BBC) implant Subjects that have completed one year follow up in Osseofon BCI (Bone Conduction Implant) study Subjects available for 6 months study procedures without affecting the follow ups in the Osseofon BCI study Active user of the BCI SP Exclusion Criteria: Inability to participate in follow-ups Unsuitable as judged by the principle investigator or the sub-investigator
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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fusion sound processor<br>The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear. | Device: Fusion Sound Processor<br>* Sound Processor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aided thresholds Fusion-unaided PTA | Difference between Fusion-aided and unaided sound field Pure Tone Average of thresholds at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aided thresholds Fusion-unaided | Difference between Fusion-aided and unaided sound field Pure Tone thresholds at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz | 6 months | 
| Aided thresholds Fusion PTA4 | Difference between Fusion-aided sound field PTA4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4) | Baseline, 1 and 6 month(s) | 
| Aided thresholds Fusion | Difference between Fusion-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz at | Baseline, 1 and 6 month(s) | 
| Aided thresholds Fusion-BCI PTA4 | Difference between Fusion-aided and BCI-aided sound field Pure Tone Average 4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA4) | 6 months | 
| Aided thresholds Fusion-BCI | Difference between Fusion-aided and BCI-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz | 6 months | 
| Speech intelligibility Fusion-unaided % | Difference between Fusion-aided and unaided speech intelligibility scores (in % correct) | 6 months | 
| Speech intelligibility Fusion-unaided signal to noise ratio (SNR) | Difference between Fusion-aided and unaided sound field speech intelligibility scores in SNR | 6 months | 
| Speech intelligibility Fusion % | Difference between Fusion-aided speech intelligibility scores (in % correct) | Baseline, 1 and 6 month(s) | 
| Speech intelligibility Fusion SNR | Difference between Fusion-aided sound field sound field speech intelligibility scores in SNR | Baseline, 1 and 6 month(s) | 
| Speech intelligibility Fusion-BCI % | Difference between Fusion-aided BCI-aided speech intelligibility scores (in % correct) | 6 months | 
| Speech intelligibility Fusion-BCI SNR | Difference between Fusion-aided and BCI-aided sound field speech intelligibility scores in SNR | 6 months | 
| Magnet strength | Difference in magnet strength measured on the patient's heads in Newton | Baseline, 1 and 6 month(s) | 
| IPS (Inflammation, Pain, Skin height/numbness) evaluation | Combined score of IPS evaluating the skin area under the sound processor. I scale ranging from 0-4, Pain scale ranging from 0-2, Skin height/numbness ranging from 0-2. Total score 0-8 (0 no adverse skin condition, 8 maximum adverse skin reactions on all subscales) | Baseline, 1 and 6 month(s) | 
| Subjective evaluation | User satisfaction and usability as measured with questionniare Usage of sound processor consisting of rating scales on satisfaction of the sound processor | Baseline, 1 and 6 month(s) | 
| Subjective evaluation SSQ | Subjective performance as measured by Speech, Spatial and Quality (SSQ) a scale from 0-10 where 0 represents Not at all and 10 represents Perfect | Baseline, 1 and 6 month(s) |