Evaluation of a Hearing Device for Transmitting Sound to the Inner Ear
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Details and patient eligibility
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 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
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
11 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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