Evaluation of Sound Processor for a Transcutaneous System
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About
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.
Full description
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.
Enrollment
Sex
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
10 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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