Clinical trial NCT05628285: Evaluation of a Hearing Device for Transmitting Sound to the Inner Ear
Official title: Evaluation of a Sound Processor for a Transcutaneous System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Conductive Hearing Loss
Mixed Hearing Loss
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2022-11-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent Form
2. Adult subjects (18 years or older)
3. Subjects implanted with an I1 implant
4. Fluent in Swedish

Exclusion Criteria:

1. 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.
2. Subject deemed unsuitable for any medical or other reason as judged by PI or medical responsible.

Primary outcomes:
measure: To assess the improvement of hearing with the Sentio1 (PTA4)
timeFrame: 1 month
Secondary outcomes:
measure: To assess the improvement of hearing with the Sentio1
timeFrame: 1 month
measure: 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.
timeFrame: 1 month
measure: Subjective sound processor preference
timeFrame: 1 month
measure: To assess the degree to which Sentio 1 compensates for the BC hearing loss
timeFrame: 1 month
measure: To assess the difference between BC in-situ thresholds measured with Sentio 1 and conventional unmasked BC audiometry.
timeFrame: 1 month
measure: Assess safety with the Sentio 1 sound processor
timeFrame: 12 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Habilitation & Health, Hearing organization
Study officials:
affiliation: Habilitation & Health, Hearing organization Södra Gubberogatan 6, 416 63 Göteborg, Sweden
name: Ann-Charlotte Persson
role: PRINCIPAL_INVESTIGATOR
References: