Evaluation of a Hearing Device for Transmitting Sound to the Inner Ear

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 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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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: Sentio 1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Form Adult subjects (18 years or older) Subjects implanted with an I1 implant Fluent in Swedish Exclusion Criteria: Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g., to complete questionnaires, according to investigator's discretion. Subject deemed unsuitable for any medical or other reason as judged by PI or medical responsible.

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: Sentio 1 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: Sentio 1<br>* Sound processor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the improvement of hearing with the Sentio1 (PTA4) | Functional gain with Sentio 1, i.e., the difference in dB between unaided and aided sound field thresholds, calculated on average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4). | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the improvement of hearing with the Sentio1 | Functional gain with Sentio 1, i.e., the difference in dB between unaided and aided sound field thresholds, for all measured frequencies. | 1 month | 
| Subjective evaluation of sound processor performance. Measured by the Speech, Spatial and Quality (SSQ) scale from 0-10 where 0 represents Not at all and 10 represents Perfect. Higher scores mean a better outcome. | Sentio 1 compared to previous sound processor. Average SSQ12 scores with Sentio 1 for each question, sub-scales and in total. Average SSQ12 scores with current sound processor for each question, sub-scales and in total. Difference in SSQ12 scores between Sentio 1 and current sound processor for each question, sub-scales and in total. | 1 month | 
| Subjective sound processor preference | Percentage (%) of subjects who prefer the Sentio 1 over current sound processor | 1 month | 
| To assess the degree to which Sentio 1 compensates for the BC hearing loss | Effective gain defined as the difference in dB between aided sound field thresholds with Sentio 1 and unmasked BC thresholds on the aided ear(s). The effective gain is calculated for all measured frequencies. Effective gain with Sentio 1, see definition above, calculated in average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4). | 1 month | 
| To assess the difference between BC in-situ thresholds measured with Sentio 1 and conventional unmasked BC audiometry. | Difference in dB between Sentio 1 BC in situ thresholds and BC thresholds measured with conventional unmasked BC audiometry for the frequencies 500, 1000, 2000, 3000 and 4000 Hz | 1 month | 
| Assess safety with the Sentio 1 sound processor | Tabulation of AEs occurred throughout the investigation and percentage of individuals with reported AEs. | 12 months |